RBW are collaborating with a leading international biotech to find an Associate Director of Regulatory Affairs Strategy, who will participate in the development and implementation of regulatory strategy for a range of therapeutic areas, including Pulmonology/Respiratory, Haematology, Diabetes and Gene therapies. The role is based in their international HQ in London. Role Responsibilities: Act as the Regional Regulatory Lead, to develop regulatory strategy for assigned products in collaboration with Global Regulatory Lead Ensure projects are appropriately prioritised and progressed in accordance with agreed regulatory plans, communicating any identified risks to project teams and Senior Management Manage the preparation and submission of technically complex regulatory submissions, with minimal supervision Provide appropriate strategic regulatory advice to Submission and Project Teams in a timely manner Keep regulatory affairs senior management informed on the status of global strategies and tactics, procedures and practices, with a focus on regulatory and policy trends in the EU Act as primary contact with Regulatory Authorities for assigned products and territories Lead local or global company process improvement initiatives Ensure all work is compliant with regulatory requirements and company policies and procedures Work with cross-department teams and key IHQ functions to achieve corporate and departmental goals and objectives. Able to plan, schedule and arrange own work activities with limited direction, exhibiting ownership and accountability for all projects and internal assignments Role Requirements: Bachelor s degree in life sciences Recent direct experience of clinical development Has led direct interactions with EMA, and national Competent Authorities on clinical development and complex regulatory submissions such as MAAs, new indications, and PIPs In-depth knowledge of regulatory landscape, including ICH and regional requirements for assigned territories and current regulatory trends Recognized as a knowledgeable resource for regulatory advice in other departments Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct Strategic ability, as evidenced by an awareness of the "big picture" strategic issues facing the business overall and positioning of local strategy relative to global and international requirements Ability to navigate and be successful in a fast-paced environment while delivering high quality results Adaptable to changing plans and able to behave independently with minimal guidance where needed, but also embraces being part of a team and working collaboratively Good interpersonal skills and ability to deal effectively with a variety of personalities Acts to promote an energizing, inclusive environment and good morale Empowers other team members through delegation of tasks and decisions Excellent communication skills, strong oral/written presentation skills. Fluent written and spoken English. Ability to travel to corporate headquarters as well as attend EU meetings as required This role provides hybrid working from home and a Central London office, and a strong culture with the support and opportunities to progress further into your career. Alongside this, my client also offers a comprehensive benefits package, including a generous bonus scheme, LTI s, healthcare, and a car allowance. My client are able to offer visa sponsorship and relocation support to candidates with relevant capabilities. If you have the skills required and would like to discuss the full details of the job, please contact Katie Dunbar on 952176, or apply with your CV.
Sep 24, 2022
Full time
RBW are collaborating with a leading international biotech to find an Associate Director of Regulatory Affairs Strategy, who will participate in the development and implementation of regulatory strategy for a range of therapeutic areas, including Pulmonology/Respiratory, Haematology, Diabetes and Gene therapies. The role is based in their international HQ in London. Role Responsibilities: Act as the Regional Regulatory Lead, to develop regulatory strategy for assigned products in collaboration with Global Regulatory Lead Ensure projects are appropriately prioritised and progressed in accordance with agreed regulatory plans, communicating any identified risks to project teams and Senior Management Manage the preparation and submission of technically complex regulatory submissions, with minimal supervision Provide appropriate strategic regulatory advice to Submission and Project Teams in a timely manner Keep regulatory affairs senior management informed on the status of global strategies and tactics, procedures and practices, with a focus on regulatory and policy trends in the EU Act as primary contact with Regulatory Authorities for assigned products and territories Lead local or global company process improvement initiatives Ensure all work is compliant with regulatory requirements and company policies and procedures Work with cross-department teams and key IHQ functions to achieve corporate and departmental goals and objectives. Able to plan, schedule and arrange own work activities with limited direction, exhibiting ownership and accountability for all projects and internal assignments Role Requirements: Bachelor s degree in life sciences Recent direct experience of clinical development Has led direct interactions with EMA, and national Competent Authorities on clinical development and complex regulatory submissions such as MAAs, new indications, and PIPs In-depth knowledge of regulatory landscape, including ICH and regional requirements for assigned territories and current regulatory trends Recognized as a knowledgeable resource for regulatory advice in other departments Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct Strategic ability, as evidenced by an awareness of the "big picture" strategic issues facing the business overall and positioning of local strategy relative to global and international requirements Ability to navigate and be successful in a fast-paced environment while delivering high quality results Adaptable to changing plans and able to behave independently with minimal guidance where needed, but also embraces being part of a team and working collaboratively Good interpersonal skills and ability to deal effectively with a variety of personalities Acts to promote an energizing, inclusive environment and good morale Empowers other team members through delegation of tasks and decisions Excellent communication skills, strong oral/written presentation skills. Fluent written and spoken English. Ability to travel to corporate headquarters as well as attend EU meetings as required This role provides hybrid working from home and a Central London office, and a strong culture with the support and opportunities to progress further into your career. Alongside this, my client also offers a comprehensive benefits package, including a generous bonus scheme, LTI s, healthcare, and a car allowance. My client are able to offer visa sponsorship and relocation support to candidates with relevant capabilities. If you have the skills required and would like to discuss the full details of the job, please contact Katie Dunbar on 952176, or apply with your CV.
Clinical Research Associate 2 / Senior CRA - (Regionalised) A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully. Wales £40,000 - £55,000 (DOE) My client, a large global organisation with a vast European presence are looking for an experienced CRA to join their business as a Senior CRA or CRA II. If you are looking for an opportunity to broaden your career, work on some truly fascinating studies in very niche therapeutic areas, or even just a genuine chance of ongoing career development then I am confident this could be the perfect organisation for you. The beauty of this client is that they focus on multiple therapy areas across all phases of the clinical trial spectrum which means no matter what your previous exposure has been there could be a perfect opportunity waiting for you. New medicine development is at the forefront of everything they do, this is a truly innovative business who are constantly looking for ways to change and better the future of the life sciences industry and as a result have been listed as one of the most admired companies to work for this year. If this isn't enough to make you want to apply then its also worth mentioning that this is a company who also take their corporate social responsibilities seriously, whether that be ways to prevent pollution and carbon emissions or more simply supporting causes that are important to their employees this is at the core of what they do. As an ARC your responsibilities will include: Coordinating Phase I-IV clinical trials Performing the full range of site visits: qualification, initiation, monitoring, motivational, audit support, and close out. Identifying and conducting feasibility assessments for proposed study sites in conjunction with the Project Team. Liaising with other appropriate departments to ensure the smooth running of the study Provide guidance and leadership to more junior CRAs (Senior CRA responsibility) Your previous experience should include: A degree in life science or related and experience of independent monitoring within clinical research, including good clinical knowledge and working understanding of GCP Regulations. In addition, previous experience within any other Clinical function would be highly advantageous. This position is home based anywhere across France and therefore flexibility to travel will be essential. To know more about this terrific company and to get a better feel for whether this position falls in line with your expectations, please speak to Paul Adam using the below contact information: (0)
Sep 24, 2022
Full time
Clinical Research Associate 2 / Senior CRA - (Regionalised) A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully. Wales £40,000 - £55,000 (DOE) My client, a large global organisation with a vast European presence are looking for an experienced CRA to join their business as a Senior CRA or CRA II. If you are looking for an opportunity to broaden your career, work on some truly fascinating studies in very niche therapeutic areas, or even just a genuine chance of ongoing career development then I am confident this could be the perfect organisation for you. The beauty of this client is that they focus on multiple therapy areas across all phases of the clinical trial spectrum which means no matter what your previous exposure has been there could be a perfect opportunity waiting for you. New medicine development is at the forefront of everything they do, this is a truly innovative business who are constantly looking for ways to change and better the future of the life sciences industry and as a result have been listed as one of the most admired companies to work for this year. If this isn't enough to make you want to apply then its also worth mentioning that this is a company who also take their corporate social responsibilities seriously, whether that be ways to prevent pollution and carbon emissions or more simply supporting causes that are important to their employees this is at the core of what they do. As an ARC your responsibilities will include: Coordinating Phase I-IV clinical trials Performing the full range of site visits: qualification, initiation, monitoring, motivational, audit support, and close out. Identifying and conducting feasibility assessments for proposed study sites in conjunction with the Project Team. Liaising with other appropriate departments to ensure the smooth running of the study Provide guidance and leadership to more junior CRAs (Senior CRA responsibility) Your previous experience should include: A degree in life science or related and experience of independent monitoring within clinical research, including good clinical knowledge and working understanding of GCP Regulations. In addition, previous experience within any other Clinical function would be highly advantageous. This position is home based anywhere across France and therefore flexibility to travel will be essential. To know more about this terrific company and to get a better feel for whether this position falls in line with your expectations, please speak to Paul Adam using the below contact information: (0)
Regional Clinical Research Associate ll The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have. £40k - £50k (D.O.E.) Generous Car Allowance, Sign-On Bonus To be based in either London, Bristol, Swindon, Wales, Dublin, Belfast At RBW we pride ourselves in taking time to understand our candidates and offer not only a true consultative approach but also, really take time to understand what's important to you and make recommendations of suitable roles based on your experience, not on which role will pay the highest commission. I am currently recruiting for a 'World-Class' CRO who are looking for their next hire due to continued expansion to be based in UK/Ireland You will work within an established team who will offer you support and guidance, along with providing you with a structured training program, ensuring you are able to work autonomously, making sure to put the quality of the trial first. Due to the nature of the role, your duties will change based on requirement however below are some of the more routine duties you will perform in this role. Coordinating phase l - lV clinical trials Performing the full suite of site visits: qualification, initiation, monitoring, motivational, audit support and close out Identifying and conducting feasibility assessments for proposed study sites in accordance with the Project team Liaising with other departments to ensure smooth running of the study Reporting on serious adverse events Checking drug accountability Previous Experience: Life Science degree or equivalent Willingness to travel Driving License Excellent communication and interpersonal skills Extensive SIV/IMV/COV 18-24 months on-site, independent monitoring experience. If you think your experience and career aspirations match the above positions, I would be very interested in hearing from you. Please call or email Paul on / (mailto:364079/)
Sep 23, 2022
Full time
Regional Clinical Research Associate ll The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have. £40k - £50k (D.O.E.) Generous Car Allowance, Sign-On Bonus To be based in either London, Bristol, Swindon, Wales, Dublin, Belfast At RBW we pride ourselves in taking time to understand our candidates and offer not only a true consultative approach but also, really take time to understand what's important to you and make recommendations of suitable roles based on your experience, not on which role will pay the highest commission. I am currently recruiting for a 'World-Class' CRO who are looking for their next hire due to continued expansion to be based in UK/Ireland You will work within an established team who will offer you support and guidance, along with providing you with a structured training program, ensuring you are able to work autonomously, making sure to put the quality of the trial first. Due to the nature of the role, your duties will change based on requirement however below are some of the more routine duties you will perform in this role. Coordinating phase l - lV clinical trials Performing the full suite of site visits: qualification, initiation, monitoring, motivational, audit support and close out Identifying and conducting feasibility assessments for proposed study sites in accordance with the Project team Liaising with other departments to ensure smooth running of the study Reporting on serious adverse events Checking drug accountability Previous Experience: Life Science degree or equivalent Willingness to travel Driving License Excellent communication and interpersonal skills Extensive SIV/IMV/COV 18-24 months on-site, independent monitoring experience. If you think your experience and career aspirations match the above positions, I would be very interested in hearing from you. Please call or email Paul on / (mailto:364079/)
EMEA GVP Consultant / Auditor Salary up £70,000 per annum plus benefits Location - home based / remote Are client, an international specialist consultancy offers a full range of independent GCP, GVP, GLP and GMP Quality Assurance and Quality Management services on a global basis. Due to company expansion they are now looking for an experienced GVP consultant / auditor to join their pharmacovigilance practice. What will the role typically involve? * Delivering projects in compliance with agreed project proposals * Project management of PV Audit programs * Performing the role of Project Lead and Client liaison * Preparation, conduct and reporting of PV system audits at clinets, service providers, marketing partners, distributors What will you bring * Strong experience conducting and leading internal and external PV audits * Expert knowledge of PV regulations and guidance with a strong focus on EU * Ability to work effectively to tight deadlines * Ability to work proactively, identify issues and dealing with solutions effectively * Willingness to travel (around 40%) For further information please contact Louise on (0)
Mar 24, 2021
Full time
EMEA GVP Consultant / Auditor Salary up £70,000 per annum plus benefits Location - home based / remote Are client, an international specialist consultancy offers a full range of independent GCP, GVP, GLP and GMP Quality Assurance and Quality Management services on a global basis. Due to company expansion they are now looking for an experienced GVP consultant / auditor to join their pharmacovigilance practice. What will the role typically involve? * Delivering projects in compliance with agreed project proposals * Project management of PV Audit programs * Performing the role of Project Lead and Client liaison * Preparation, conduct and reporting of PV system audits at clinets, service providers, marketing partners, distributors What will you bring * Strong experience conducting and leading internal and external PV audits * Expert knowledge of PV regulations and guidance with a strong focus on EU * Ability to work effectively to tight deadlines * Ability to work proactively, identify issues and dealing with solutions effectively * Willingness to travel (around 40%) For further information please contact Louise on (0)
Global Senior Clinical Project Manager - Home Based I am partnering with a growing company who are expanding their European operations team and are looking for a Senior Clinical Project Manager to oversee some very interesting and important European trials. The company are a full-service Clinical Research company and have the patients in their trials at the forefront of everything they do. They have very strong connections with a number of small innovative biotech's in America and want to help them expand their research further across the globe. The position will be fully remote but will involve elements of travel for meetings, and eventually following the end of Covid for social interactions with the wider team. The position will involve gaining approval for trials in a number of worldwide countries so previous experience of working within the Global or European market would be preferred, as would previous working experience of being a CRA. The responsibilities will include overseeing the monitoring team across multiple countries so an understanding of what works best for CRAs is important. I am looking to speak with Clinical Experts who have experience working as a Project Manager and have developed protocols for niche trials in the past. Due to the company being small currently in Europe there will be a number of additional responsibilities that perhaps would be done by additional staff in a larger organisation. My client are looking for someone who has worked for a small organisation in the past or is very used to being very hands on with trials and carrying out many additional tasks. The company currently have a "roll your sleeves up and get everything done" attitude and need people who have a similar mentality. My client is offering an attractive financial package as well as the benefit of working from home, and future opportunities to progress your career with a growing and innovative organisation. If you feel this opportunity or something similar could be of interest to you, please get in touch and we can discuss this role but also what other vacancies we current have available and find out exactly what you are looking for in the future. My name is Alex Goodman and I solely recruit Clinical experts and have connections with several large and small organisations who are always looking for high calibre talent to join their exciting teams. If you work in any Clinical function and would like to discuss potential new opportunities, please do not hesitate to contact me. At RBW Consulting Ltd, every one of our consultants has one specific area of expertise ensuring they excel in helping Life Sciences Professionals find the jobs they are looking for in the industry. With unrivalled industry knowledge and excellent links with hiring managers in Biotech's, Pharma's and CROs throughout the UK, Europe and across the world, we would be delighted to speak with you about the role you are looking for.
Mar 23, 2021
Full time
Global Senior Clinical Project Manager - Home Based I am partnering with a growing company who are expanding their European operations team and are looking for a Senior Clinical Project Manager to oversee some very interesting and important European trials. The company are a full-service Clinical Research company and have the patients in their trials at the forefront of everything they do. They have very strong connections with a number of small innovative biotech's in America and want to help them expand their research further across the globe. The position will be fully remote but will involve elements of travel for meetings, and eventually following the end of Covid for social interactions with the wider team. The position will involve gaining approval for trials in a number of worldwide countries so previous experience of working within the Global or European market would be preferred, as would previous working experience of being a CRA. The responsibilities will include overseeing the monitoring team across multiple countries so an understanding of what works best for CRAs is important. I am looking to speak with Clinical Experts who have experience working as a Project Manager and have developed protocols for niche trials in the past. Due to the company being small currently in Europe there will be a number of additional responsibilities that perhaps would be done by additional staff in a larger organisation. My client are looking for someone who has worked for a small organisation in the past or is very used to being very hands on with trials and carrying out many additional tasks. The company currently have a "roll your sleeves up and get everything done" attitude and need people who have a similar mentality. My client is offering an attractive financial package as well as the benefit of working from home, and future opportunities to progress your career with a growing and innovative organisation. If you feel this opportunity or something similar could be of interest to you, please get in touch and we can discuss this role but also what other vacancies we current have available and find out exactly what you are looking for in the future. My name is Alex Goodman and I solely recruit Clinical experts and have connections with several large and small organisations who are always looking for high calibre talent to join their exciting teams. If you work in any Clinical function and would like to discuss potential new opportunities, please do not hesitate to contact me. At RBW Consulting Ltd, every one of our consultants has one specific area of expertise ensuring they excel in helping Life Sciences Professionals find the jobs they are looking for in the industry. With unrivalled industry knowledge and excellent links with hiring managers in Biotech's, Pharma's and CROs throughout the UK, Europe and across the world, we would be delighted to speak with you about the role you are looking for.
Geoff King at RBW Consulting is supporting a game-changing CRO that is reinventing the way therapies are developed in the recruitment of a Principal Biostatistician to join a multi-sponsor Oncology team. As a forward thinking, top 10 global CRO you will have the opportunity to work with some of the biggest and best pharmaceutical companies in the world on blockbuster drug trials. You will have excellent training and development opportunities, competitive salary & benefits and the chance to improve patients' lives around the world. *Responsibilities* * Develop department Standard Operating Procedures (SOPs) and guidelines * Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and SOPs, and conducts projects within budget. * Responsible for staff development, training and retention. * Participates actively in hiring, onboarding, transferring, and terminating staff. * Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines. * Supports the assignment of, or directly assigns Biostatisticians to projects * Supports business development activities. * Minimal travel may be required. *Requirements:* * Extensive experience in statistical analysis of clinical or consumer health trials as demonstrated by the ability to lead multiple complex and/or global projects with teams of statisticians * Previous management experience of remote teams * Strong statistical skills as evidenced by participation in publications or presentations in areas relevant to clinical trial design and analysis * Proficiency in SAS programming * Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade * Ability to travel may be required A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Mar 23, 2021
Full time
Geoff King at RBW Consulting is supporting a game-changing CRO that is reinventing the way therapies are developed in the recruitment of a Principal Biostatistician to join a multi-sponsor Oncology team. As a forward thinking, top 10 global CRO you will have the opportunity to work with some of the biggest and best pharmaceutical companies in the world on blockbuster drug trials. You will have excellent training and development opportunities, competitive salary & benefits and the chance to improve patients' lives around the world. *Responsibilities* * Develop department Standard Operating Procedures (SOPs) and guidelines * Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and SOPs, and conducts projects within budget. * Responsible for staff development, training and retention. * Participates actively in hiring, onboarding, transferring, and terminating staff. * Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines. * Supports the assignment of, or directly assigns Biostatisticians to projects * Supports business development activities. * Minimal travel may be required. *Requirements:* * Extensive experience in statistical analysis of clinical or consumer health trials as demonstrated by the ability to lead multiple complex and/or global projects with teams of statisticians * Previous management experience of remote teams * Strong statistical skills as evidenced by participation in publications or presentations in areas relevant to clinical trial design and analysis * Proficiency in SAS programming * Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade * Ability to travel may be required A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Clinical Research Organisations are a hot topic right now, and quite rightly so. And as a Statistical Programmer for this particular CRO, you'll be at the forefront of some seriously career-defining projects - particularly as this organisation is one of the world's leading innovators in healthcare and drug discovery. Bringing healthcare data, domain expertise, transformative technology and advanced analytics into a mixing pot of genius, they're utilising the most cutting-edge technology to deliver life-changing results. Striving for nothing short of excellence, they're embarking on an exciting new era of data science, with capabilities that extend from AI and machine learning to virtual trials - and in the process, they continue to create the most exceptional career prospects for their ambitious workforce. *The role:* With multiple opportunities across Europe for both Senior Programmer and Principal Programmers, you'll be part of a vibrant Statistical Programming directorate that has access to sector-leading technology. Joining a specialist, single sponsor team on multiple complex global studies across phases I-IV, you'll be entrusted with the most spectacular trials, developing the process methodologies and quality controls needed for various departments to meet their internal and external clients' needs. With the opportunity to provide technical expertise and leadership across the department, you'll shape and coordinate the development of integrated programming solutions, and you will deliver internal consulting expertise, formulating specifications and user needs analyses for complex project and client requirements. So we've established that the work will be interesting. But it's also worth noting that this role comes with the chance to pursue your long-term career goals. With exceptional training and development opportunities that will be tailored to your needs (including the chance to maintain up-to-date advanced knowledge of programming software and CDISC requirements), you'll have first dibs on the most interesting promotions - so there really is no saying where your career will take you next. *To make waves in this exceptional Statistical Programming team, you will:* * Have experience in statistical programming in SAS within the CRO, pharmaceutical or biotechnology sectors. * Boast a comprehensive knowledge of statistics and programming within the clinical drug development process. * Have a brilliant awareness of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language. * Be organised. You'll be leading projects at a group level, so you will know how to blow expectations out of the water, while always meeting deadlines. * Have the qualifications or experience to prove that you're up to the job. A degree in computer science would be a bonus. * Be highly analytical with an in-depth knowledge of clinical research regulatory requirements. * Be inspirational, with good communication and influencing skills. In other words, you'll be capable of managing a visionary programming team and helping them achieve their best.
Mar 23, 2021
Full time
Clinical Research Organisations are a hot topic right now, and quite rightly so. And as a Statistical Programmer for this particular CRO, you'll be at the forefront of some seriously career-defining projects - particularly as this organisation is one of the world's leading innovators in healthcare and drug discovery. Bringing healthcare data, domain expertise, transformative technology and advanced analytics into a mixing pot of genius, they're utilising the most cutting-edge technology to deliver life-changing results. Striving for nothing short of excellence, they're embarking on an exciting new era of data science, with capabilities that extend from AI and machine learning to virtual trials - and in the process, they continue to create the most exceptional career prospects for their ambitious workforce. *The role:* With multiple opportunities across Europe for both Senior Programmer and Principal Programmers, you'll be part of a vibrant Statistical Programming directorate that has access to sector-leading technology. Joining a specialist, single sponsor team on multiple complex global studies across phases I-IV, you'll be entrusted with the most spectacular trials, developing the process methodologies and quality controls needed for various departments to meet their internal and external clients' needs. With the opportunity to provide technical expertise and leadership across the department, you'll shape and coordinate the development of integrated programming solutions, and you will deliver internal consulting expertise, formulating specifications and user needs analyses for complex project and client requirements. So we've established that the work will be interesting. But it's also worth noting that this role comes with the chance to pursue your long-term career goals. With exceptional training and development opportunities that will be tailored to your needs (including the chance to maintain up-to-date advanced knowledge of programming software and CDISC requirements), you'll have first dibs on the most interesting promotions - so there really is no saying where your career will take you next. *To make waves in this exceptional Statistical Programming team, you will:* * Have experience in statistical programming in SAS within the CRO, pharmaceutical or biotechnology sectors. * Boast a comprehensive knowledge of statistics and programming within the clinical drug development process. * Have a brilliant awareness of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language. * Be organised. You'll be leading projects at a group level, so you will know how to blow expectations out of the water, while always meeting deadlines. * Have the qualifications or experience to prove that you're up to the job. A degree in computer science would be a bonus. * Be highly analytical with an in-depth knowledge of clinical research regulatory requirements. * Be inspirational, with good communication and influencing skills. In other words, you'll be capable of managing a visionary programming team and helping them achieve their best.
Geoff King at RBW Consulting is recruiting for a Senior or Principal Statistician to join a market leading immunology business with specialist experience in the research and development of allergy treatments as they look to continue on an exciting period of growth for the company. This mid-size organisation are passionate in their ambition to transform patients' lives through the ideas and products they bring to market covering such life impacting areas such as hayfever, pet and food allergies. With an exciting and varied pipeline from Phase I - III and post marketing this is a great time to join an organisation which is sure to become a household name. As sole Statistician you will play an important part in delivering these important and life changing drugs to market. In addition to working on being the lead Statistician on multiple projects you will review / author SAPs, sections of the clinical study report and act as primary point of contact with all CRO/vendors for all biostatistics related activities. If you are an experienced and driven Biostatistician who wants to have a direct impact on the successful launch of life changing treatments and are able to work flexibly across a multi-functional and collaborative team then this would be a fantastic opportunity for you. *Main duties & responsibilities:* * Lead statistician for multiple projects. * Responsible for all statistical aspects of clinical trial including trial design, programming, analysis and regulatory filing strategy. * Collaborates with applicable study team members in the process of outlining the clinical development. * Authors and/or reviews Statistical Analysis Plans (SAPs). * Authors/reviews sections of the clinical study report. * Acts as the primary contact with CRO/Vendors for all biostatistics related activities on assigned projects. *Key requirements:* * PhD or MSc in Statistics or Biostatistics combined with relevant experience within the pharmaceutical industry. * Advanced knowledge of clinical study designs and common statistical analysis methods. * Extensive knowledge of MHRA, FDA and ICH regulations and industry standards. * Good knowledge of statistical programming languages and statistical software (eg. SAS, R, East etc). * Excellent communication skills. * Positive "can do" attitude. A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page.
Mar 23, 2021
Full time
Geoff King at RBW Consulting is recruiting for a Senior or Principal Statistician to join a market leading immunology business with specialist experience in the research and development of allergy treatments as they look to continue on an exciting period of growth for the company. This mid-size organisation are passionate in their ambition to transform patients' lives through the ideas and products they bring to market covering such life impacting areas such as hayfever, pet and food allergies. With an exciting and varied pipeline from Phase I - III and post marketing this is a great time to join an organisation which is sure to become a household name. As sole Statistician you will play an important part in delivering these important and life changing drugs to market. In addition to working on being the lead Statistician on multiple projects you will review / author SAPs, sections of the clinical study report and act as primary point of contact with all CRO/vendors for all biostatistics related activities. If you are an experienced and driven Biostatistician who wants to have a direct impact on the successful launch of life changing treatments and are able to work flexibly across a multi-functional and collaborative team then this would be a fantastic opportunity for you. *Main duties & responsibilities:* * Lead statistician for multiple projects. * Responsible for all statistical aspects of clinical trial including trial design, programming, analysis and regulatory filing strategy. * Collaborates with applicable study team members in the process of outlining the clinical development. * Authors and/or reviews Statistical Analysis Plans (SAPs). * Authors/reviews sections of the clinical study report. * Acts as the primary contact with CRO/Vendors for all biostatistics related activities on assigned projects. *Key requirements:* * PhD or MSc in Statistics or Biostatistics combined with relevant experience within the pharmaceutical industry. * Advanced knowledge of clinical study designs and common statistical analysis methods. * Extensive knowledge of MHRA, FDA and ICH regulations and industry standards. * Good knowledge of statistical programming languages and statistical software (eg. SAS, R, East etc). * Excellent communication skills. * Positive "can do" attitude. A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page.
Geoff King at RBW Consulting is working with a specialist Clinical Research Organisation to the pharmaceutical industry in the recruitment of multiple Senior or Principal Biostatisticians to join their FSP and embedded model teams as they continue to support a number of the worlds most cutting edge pharmaceutical companies. As a CRO focused on delivering high quality statistics and programming support to these companies you will have the opportunity to work across multiple therapeutic area on phase I-IV clinical trials. This company prides themselves on their friendly and supportive culture where you will receive help on trials no matter how big or small the request. They also provide constant opportunities for promotion and growth due to their investment on staff and defined career plans. *Main duties & responsibilities:* • Perform technical and consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs. • Author simple and complex study SAP and TFL shells. • Author and review simple and complex dataset standards. • Perform data checks and data exploration (e.g. using frequencies, histograms). • Identify data and standards issues and resolve or escalate as appropriate. • Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications, applying good programming practice. • Application of complex statistical techniques (e.g. mixed effects, non-linear modelling, Bayesian, advanced survival), model checking and interpretation. • Perform literature review and ability to extract and collate relevant information and data from external papers as needed. • Identify and implement appropriate sample size method using software or simulations. • Support study team in providing study design options. • Review of project management related documents. • Maintain study master file documents and any other documents that are required to be audit ready. • Lead internal and client study team meetings effectively. *Key requirements:* • MSc or PhD in Statistics/Biostatistics (or equivalent). • At least 3 years of relevant industry experience. • Understanding of clinical drug development process, relevant disease areas, endpoints and different study designs. • Awareness of industry and project standards & ICH guidelines. • Excellent verbal and written communication skills. A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page.
Mar 23, 2021
Full time
Geoff King at RBW Consulting is working with a specialist Clinical Research Organisation to the pharmaceutical industry in the recruitment of multiple Senior or Principal Biostatisticians to join their FSP and embedded model teams as they continue to support a number of the worlds most cutting edge pharmaceutical companies. As a CRO focused on delivering high quality statistics and programming support to these companies you will have the opportunity to work across multiple therapeutic area on phase I-IV clinical trials. This company prides themselves on their friendly and supportive culture where you will receive help on trials no matter how big or small the request. They also provide constant opportunities for promotion and growth due to their investment on staff and defined career plans. *Main duties & responsibilities:* • Perform technical and consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs. • Author simple and complex study SAP and TFL shells. • Author and review simple and complex dataset standards. • Perform data checks and data exploration (e.g. using frequencies, histograms). • Identify data and standards issues and resolve or escalate as appropriate. • Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications, applying good programming practice. • Application of complex statistical techniques (e.g. mixed effects, non-linear modelling, Bayesian, advanced survival), model checking and interpretation. • Perform literature review and ability to extract and collate relevant information and data from external papers as needed. • Identify and implement appropriate sample size method using software or simulations. • Support study team in providing study design options. • Review of project management related documents. • Maintain study master file documents and any other documents that are required to be audit ready. • Lead internal and client study team meetings effectively. *Key requirements:* • MSc or PhD in Statistics/Biostatistics (or equivalent). • At least 3 years of relevant industry experience. • Understanding of clinical drug development process, relevant disease areas, endpoints and different study designs. • Awareness of industry and project standards & ICH guidelines. • Excellent verbal and written communication skills. A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page.
Geoff King at RBW Consulting is recruiting for multiple, permanent Principal Statistical Programmers to join a leading pharmaceutical company as they look to grow a new team of Programmers and Statisticians in the UK focused on the Oncology therapeutic area. This position is fully home based but must be in the UK. Principal level Statistical Programmers are required for this science-led healthcare company who have an incredibly exciting range of products in the pipeline across multiple therapeutic area's including Respiratory, Infectious Disease, Immuno-Inflammatory and Oncology. As a Statistical Programmer you will play an important part in delivering the companies mission in helping people to do more, feel better and live longer. As part of a diverse, global team you will have the opportunity to work in an environment where you realise your full potential and achieve your career goals. *Main duties & responsibilities:* * Contribute to the delivery SDTM/ADaM datasets and TFL outputs * Contribute to the statistical programming deliverables for regulatory submissions * Produce and maintain technical database standards and programming specification documents * Contribute to the development of best practice to improve quality, efficiency and effectiveness * Prepare graphs, tables and listings for inclusion in clinical study reports *Key requirements:* * BSc in Mathematics, Statistics, Computer Science or related field * SAS programming experience working within a clinical trials environment (Pharma, CRO or biotech) * Knowledge of CDSIC standards and industry best practices * Excellent written and verbal communication skills * Ability to communicate with a broad range of people across different functions A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Mar 23, 2021
Full time
Geoff King at RBW Consulting is recruiting for multiple, permanent Principal Statistical Programmers to join a leading pharmaceutical company as they look to grow a new team of Programmers and Statisticians in the UK focused on the Oncology therapeutic area. This position is fully home based but must be in the UK. Principal level Statistical Programmers are required for this science-led healthcare company who have an incredibly exciting range of products in the pipeline across multiple therapeutic area's including Respiratory, Infectious Disease, Immuno-Inflammatory and Oncology. As a Statistical Programmer you will play an important part in delivering the companies mission in helping people to do more, feel better and live longer. As part of a diverse, global team you will have the opportunity to work in an environment where you realise your full potential and achieve your career goals. *Main duties & responsibilities:* * Contribute to the delivery SDTM/ADaM datasets and TFL outputs * Contribute to the statistical programming deliverables for regulatory submissions * Produce and maintain technical database standards and programming specification documents * Contribute to the development of best practice to improve quality, efficiency and effectiveness * Prepare graphs, tables and listings for inclusion in clinical study reports *Key requirements:* * BSc in Mathematics, Statistics, Computer Science or related field * SAS programming experience working within a clinical trials environment (Pharma, CRO or biotech) * Knowledge of CDSIC standards and industry best practices * Excellent written and verbal communication skills * Ability to communicate with a broad range of people across different functions A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Geoff King at RBW Consulting is recruiting for multiple, permanent Senior & Principal Statisticians to join a leading pharmaceutical company as they look to expand their existing teams in the UK and US. This position is office based in London or Hertfordshire with 1-2 days home work flexibility. Senior & Principal level Statisticians are required for this science-led healthcare company who have an incredibly exciting range of products in the pipeline across multiple therapeutic area's including Respiratory, Infectious Disease, Immuno-Inflammatory and more. As a Statistician you will play an important part in delivering the companies mission in helping people to do more, feel better and live longer. As part of a diverse, global team you will have the opportunity to work in an environment where you realise your full potential and achieve your career goals. *Main duties & responsibilities:* * Providing statistical expertise to support the design and interpretation of clinical programs, regulatory submissions and commercialisation * Analysing internal and external information to inform design decisions and the development of decision criteria * Providing support to the regulatory submissions including specification of overview documents and response to regulatory questions * Identifying opportunities for the application of modelling and simulation to improve study design *Key requirements:* * PhD or MSc in Statistics or Biostatistics combined with relevant experience within the pharmaceutical industry * Advanced knowledge of clinical study designs and common statistical analysis methods * Extensive knowledge of FDA and ICH regulations and industry standards * Good knowledge of statistical programming languages and statistical software (eg. SAS, R, East etc) * Excellent communication skills A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Mar 23, 2021
Full time
Geoff King at RBW Consulting is recruiting for multiple, permanent Senior & Principal Statisticians to join a leading pharmaceutical company as they look to expand their existing teams in the UK and US. This position is office based in London or Hertfordshire with 1-2 days home work flexibility. Senior & Principal level Statisticians are required for this science-led healthcare company who have an incredibly exciting range of products in the pipeline across multiple therapeutic area's including Respiratory, Infectious Disease, Immuno-Inflammatory and more. As a Statistician you will play an important part in delivering the companies mission in helping people to do more, feel better and live longer. As part of a diverse, global team you will have the opportunity to work in an environment where you realise your full potential and achieve your career goals. *Main duties & responsibilities:* * Providing statistical expertise to support the design and interpretation of clinical programs, regulatory submissions and commercialisation * Analysing internal and external information to inform design decisions and the development of decision criteria * Providing support to the regulatory submissions including specification of overview documents and response to regulatory questions * Identifying opportunities for the application of modelling and simulation to improve study design *Key requirements:* * PhD or MSc in Statistics or Biostatistics combined with relevant experience within the pharmaceutical industry * Advanced knowledge of clinical study designs and common statistical analysis methods * Extensive knowledge of FDA and ICH regulations and industry standards * Good knowledge of statistical programming languages and statistical software (eg. SAS, R, East etc) * Excellent communication skills A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Geoff King at RBW Consulting has engaged with one of the world's recognised specialist biometrics CROs supporting global pharma, biotech and medical device companies as they embark on an exciting period of growth. Due to organic growth, this company now require a Principal Statistician who shares the company values of providing a high quality, professional service in a flexible and rewarding work environment. You will be responsible for leading all statistical activities relating to clinical trial projects. Being a statistical expert able to provide statistical consultancy in specific areas. Having recently won a prestigious national award for innovation, this company pride themselves on their renowned team of biometrics experts pushing the boundaries of what biometrics can provide to the pharmaceutical industry and actively encourage input to improve processes and SOPs. Supported by an award winning in-house system, this is position is able to be worked remotely within the UK. *Main duties & responsibilities:* * Providing statistical expertise as main point of contact to sponsors and internal teams * Design, Protocol and sample size consultancy * Leading projects and delivering on time & within budget * Development of SAPs * Lead the expansion of expertise across a variety of statistical areas * Contributing to development of new systems, SOPs and processes *Key requirements:* * Statistics experience within the CRO/Pharmaceutical/Biotechnology industries * Strong analytical and data interpretation skills * Project management / study lead experience * Subject Matter Expert * Commercial awareness, budgeting, resource allocation etc * Degree in Statistics, Mathematics or related field and 5+ years relevant experience A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Mar 22, 2021
Full time
Geoff King at RBW Consulting has engaged with one of the world's recognised specialist biometrics CROs supporting global pharma, biotech and medical device companies as they embark on an exciting period of growth. Due to organic growth, this company now require a Principal Statistician who shares the company values of providing a high quality, professional service in a flexible and rewarding work environment. You will be responsible for leading all statistical activities relating to clinical trial projects. Being a statistical expert able to provide statistical consultancy in specific areas. Having recently won a prestigious national award for innovation, this company pride themselves on their renowned team of biometrics experts pushing the boundaries of what biometrics can provide to the pharmaceutical industry and actively encourage input to improve processes and SOPs. Supported by an award winning in-house system, this is position is able to be worked remotely within the UK. *Main duties & responsibilities:* * Providing statistical expertise as main point of contact to sponsors and internal teams * Design, Protocol and sample size consultancy * Leading projects and delivering on time & within budget * Development of SAPs * Lead the expansion of expertise across a variety of statistical areas * Contributing to development of new systems, SOPs and processes *Key requirements:* * Statistics experience within the CRO/Pharmaceutical/Biotechnology industries * Strong analytical and data interpretation skills * Project management / study lead experience * Subject Matter Expert * Commercial awareness, budgeting, resource allocation etc * Degree in Statistics, Mathematics or related field and 5+ years relevant experience A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Geoff King at RBW Consulting is recruiting for multiple, permanent Senior & Principal Statistical Programmers to join a leading pharmaceutical company as they look to expand their existing teams in the UK and US. This position is office based in London or Hertfordshire with 1-2 days home work flexibility. Senior & Principal level Statistical Programmers are required for this science-led healthcare company who have an incredibly exciting range of products in the pipeline across multiple therapeutic area's including Respiratory, Infectious Disease, Immuno-Inflammatory and more. As a Statistical Programmer you will play an important part in delivering the companies mission in helping people to do more, feel better and live longer. As part of a diverse, global team you will have the opportunity to work in an environment where you realise your full potential and achieve your career goals. *Main duties & responsibilities:* * Contribute to the delivery SDTM/ADaM datasets and TFL outputs * Contribute to the statistical programming deliverables for regulatory submissions * Produce and maintain technical database standards and programming specification documents * Contribute to the development of best practice to improve quality, efficiency and effectiveness * Prepare graphs, tables and listings for inclusion in clinical study reports *Key requirements:* * BSc in Mathematics, Statistics, Computer Science or related field * SAS programming experience working within a clinical trials environment (Pharma, CRO or biotech) * Knowledge of CDSIC standards and industry best practices * Excellent written and verbal communication skills * Ability to communicate with a broad range of people across different functions A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Mar 22, 2021
Full time
Geoff King at RBW Consulting is recruiting for multiple, permanent Senior & Principal Statistical Programmers to join a leading pharmaceutical company as they look to expand their existing teams in the UK and US. This position is office based in London or Hertfordshire with 1-2 days home work flexibility. Senior & Principal level Statistical Programmers are required for this science-led healthcare company who have an incredibly exciting range of products in the pipeline across multiple therapeutic area's including Respiratory, Infectious Disease, Immuno-Inflammatory and more. As a Statistical Programmer you will play an important part in delivering the companies mission in helping people to do more, feel better and live longer. As part of a diverse, global team you will have the opportunity to work in an environment where you realise your full potential and achieve your career goals. *Main duties & responsibilities:* * Contribute to the delivery SDTM/ADaM datasets and TFL outputs * Contribute to the statistical programming deliverables for regulatory submissions * Produce and maintain technical database standards and programming specification documents * Contribute to the development of best practice to improve quality, efficiency and effectiveness * Prepare graphs, tables and listings for inclusion in clinical study reports *Key requirements:* * BSc in Mathematics, Statistics, Computer Science or related field * SAS programming experience working within a clinical trials environment (Pharma, CRO or biotech) * Knowledge of CDSIC standards and industry best practices * Excellent written and verbal communication skills * Ability to communicate with a broad range of people across different functions A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
In our health-obsessed world, clinical research and end-to-end drug development services have never been more important. Done well, they're great. But done really, really well, and they have the scope to seamlessly integrate better healthcare solutions into patients' lives. Suffice to say that this organisation definitely falls into the second camp. Currently in the midst of exponential global growth, they're witnessing an average of 6 employees returning to the team every month - which speaks volumes about the kind of working environment they offer (particularly as their benefits packages are matched by sector-leading training and development opportunities). Join their well-established (and highly respected) team of Data Managers, and your career potential will rocket. *The role:* This is an exciting chance to be outsourced to work exclusively for a global pharmaceutical company - an organisation with an equally supportive and flexible culture. Better still, they're responsible for the most impressive trials across a wide variety of therapeutic areas including Cardiology, Ophthalmology, Oncology, Neurology and more, so there's immense scope to get involved in the most interesting projects. Join them as a Lead Data Manager, and you will be responsible for the implementation and development of phase 1-4 clinical trials across all of these areas (and more). Taking ownership of all project deliverables and key study metrics, every day will present you with new challenges and opportunities. Specifically, you will manage a team of UK and EU Clinical Data Associates, leading by example as you develop and implement the Data Management and Data Validation Plans. Taking an innovative approach to solving process and technical issues, you'll report on the status of your projects and tasks, and you'll track all data queries. In short, you'll be at the heart of life-changing studies, and you'll use your multitasking skills to handle everything from reconciling external data to managing key internal and external stakeholders. *To deliver the results that this Data Manager role deserves, you will: * * Have at least three years of experience in data management in either the CRO or pharmaceutical sectors. * Have the communication, influencing and leadership skills required to get the best out of a talented team. * Have a degree-level qualification, ideally in a life science subject. * Enjoy project management and delivery. Which also means you'll be capable of balancing the needs of multiple projects… and your time-management skills will be impressive. * Ideally have a knowledge of Medidata Rave - though it's not a deal breaker if you haven't got this particular skill, as long as you're proficient in at least one clinical data management system. * Be passionate about bringing life-improving drugs to market.
Mar 22, 2021
Full time
In our health-obsessed world, clinical research and end-to-end drug development services have never been more important. Done well, they're great. But done really, really well, and they have the scope to seamlessly integrate better healthcare solutions into patients' lives. Suffice to say that this organisation definitely falls into the second camp. Currently in the midst of exponential global growth, they're witnessing an average of 6 employees returning to the team every month - which speaks volumes about the kind of working environment they offer (particularly as their benefits packages are matched by sector-leading training and development opportunities). Join their well-established (and highly respected) team of Data Managers, and your career potential will rocket. *The role:* This is an exciting chance to be outsourced to work exclusively for a global pharmaceutical company - an organisation with an equally supportive and flexible culture. Better still, they're responsible for the most impressive trials across a wide variety of therapeutic areas including Cardiology, Ophthalmology, Oncology, Neurology and more, so there's immense scope to get involved in the most interesting projects. Join them as a Lead Data Manager, and you will be responsible for the implementation and development of phase 1-4 clinical trials across all of these areas (and more). Taking ownership of all project deliverables and key study metrics, every day will present you with new challenges and opportunities. Specifically, you will manage a team of UK and EU Clinical Data Associates, leading by example as you develop and implement the Data Management and Data Validation Plans. Taking an innovative approach to solving process and technical issues, you'll report on the status of your projects and tasks, and you'll track all data queries. In short, you'll be at the heart of life-changing studies, and you'll use your multitasking skills to handle everything from reconciling external data to managing key internal and external stakeholders. *To deliver the results that this Data Manager role deserves, you will: * * Have at least three years of experience in data management in either the CRO or pharmaceutical sectors. * Have the communication, influencing and leadership skills required to get the best out of a talented team. * Have a degree-level qualification, ideally in a life science subject. * Enjoy project management and delivery. Which also means you'll be capable of balancing the needs of multiple projects… and your time-management skills will be impressive. * Ideally have a knowledge of Medidata Rave - though it's not a deal breaker if you haven't got this particular skill, as long as you're proficient in at least one clinical data management system. * Be passionate about bringing life-improving drugs to market.
In our health-obsessed world, clinical research and end-to-end drug development services have never been more important. Done well, they're great. But done really, really well, and they have the scope to seamlessly integrate better healthcare solutions into patients' lives. Suffice to say that this organisation definitely falls into the second camp. Currently in the midst of exponential global growth, they're witnessing an average of 6 employees returning to the team every month - which speaks volumes about the kind of working environment they offer (particularly as their benefits packages are matched by sector-leading training and development opportunities). Join their well-established (and highly respected) team of Data Managers, and your career potential will rocket. *The role:* This is an exciting chance to be outsourced to work exclusively for a global pharmaceutical company - an organisation with an equally supportive and flexible culture. Better still, they're responsible for the most impressive trials across a wide variety of therapeutic areas including Cardiology, Ophthalmology, Oncology, Neurology and more, so there's immense scope to get involved in the most interesting projects. Join them as a Lead Data Manager, and you will be responsible for the implementation and development of phase 1-4 clinical trials across all of these areas (and more). Taking ownership of all project deliverables and key study metrics, every day will present you with new challenges and opportunities. Specifically, you will manage a team of UK and EU Clinical Data Associates, leading by example as you develop and implement the Data Management and Data Validation Plans. Taking an innovative approach to solving process and technical issues, you'll report on the status of your projects and tasks, and you'll track all data queries. In short, you'll be at the heart of life-changing studies, and you'll use your multitasking skills to handle everything from reconciling external data to managing key internal and external stakeholders. *To deliver the results that this Data Manager role deserves, you will: * * Have at least three years of experience in data management in either the CRO or pharmaceutical sectors. * Have the communication, influencing and leadership skills required to get the best out of a talented team. * Have a degree-level qualification, ideally in a life science subject. * Enjoy project management and delivery. Which also means you'll be capable of balancing the needs of multiple projects… and your time-management skills will be impressive. * Ideally have a knowledge of Medidata Rave - though it's not a deal breaker if you haven't got this particular skill, as long as you're proficient in at least one clinical data management system. * Be passionate about bringing life-improving drugs to market.
Mar 22, 2021
Full time
In our health-obsessed world, clinical research and end-to-end drug development services have never been more important. Done well, they're great. But done really, really well, and they have the scope to seamlessly integrate better healthcare solutions into patients' lives. Suffice to say that this organisation definitely falls into the second camp. Currently in the midst of exponential global growth, they're witnessing an average of 6 employees returning to the team every month - which speaks volumes about the kind of working environment they offer (particularly as their benefits packages are matched by sector-leading training and development opportunities). Join their well-established (and highly respected) team of Data Managers, and your career potential will rocket. *The role:* This is an exciting chance to be outsourced to work exclusively for a global pharmaceutical company - an organisation with an equally supportive and flexible culture. Better still, they're responsible for the most impressive trials across a wide variety of therapeutic areas including Cardiology, Ophthalmology, Oncology, Neurology and more, so there's immense scope to get involved in the most interesting projects. Join them as a Lead Data Manager, and you will be responsible for the implementation and development of phase 1-4 clinical trials across all of these areas (and more). Taking ownership of all project deliverables and key study metrics, every day will present you with new challenges and opportunities. Specifically, you will manage a team of UK and EU Clinical Data Associates, leading by example as you develop and implement the Data Management and Data Validation Plans. Taking an innovative approach to solving process and technical issues, you'll report on the status of your projects and tasks, and you'll track all data queries. In short, you'll be at the heart of life-changing studies, and you'll use your multitasking skills to handle everything from reconciling external data to managing key internal and external stakeholders. *To deliver the results that this Data Manager role deserves, you will: * * Have at least three years of experience in data management in either the CRO or pharmaceutical sectors. * Have the communication, influencing and leadership skills required to get the best out of a talented team. * Have a degree-level qualification, ideally in a life science subject. * Enjoy project management and delivery. Which also means you'll be capable of balancing the needs of multiple projects… and your time-management skills will be impressive. * Ideally have a knowledge of Medidata Rave - though it's not a deal breaker if you haven't got this particular skill, as long as you're proficient in at least one clinical data management system. * Be passionate about bringing life-improving drugs to market.
Geoff King at RBW Consulting is looking to recruit level II, Senior, Principal and Senior Principal Statistical Programmer to work for a global CRO recently announced as one of the top places to work by the international publication Forbes. This highly respected CRO pride themselves in their collaborative work culture and social impact spanning over 80 countries worldwide and invite you to become part of this exciting period of growth for the company. Due to continued expansion, we are looking to hire Statistical Programmers at all levels for fully home based vacancies in the UK and Europe to work on multiple therapeutic areas as part of the global full service team or client specific FSP model. You will have the opportunity to lead studies and will be expected to have knowledge of CDISC standards and SDTM/ADaM datasets. Supported by cutting edge technology and a collaborative team of industry experts this organisation gives you the opportunity to work at the forefront of the pharmaceutical industry. Salaries are dependent on experience ranging from £40,000 - £80,000 + additional financial incentives and career paths range from line management to subject matter expert and will be tailored specifically to you. *Main duties & responsibilities:* * Provide experienced technical expertise to develop process methodology for department to meet internal and external clients' needs. * Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. * Provide technical expertise and leadership to the department. * Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. * A crucial aspect is to maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml). * Attend functional meetings and training *Key requirements:* * Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology industries * Knowledge of statistics, programming and/or clinical drug development process * Advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language * Ability to lead teams and projects and capable of managing at a group level * Degree in computer science or related field and 3 years relevant experience A comprehensive job description for your level is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Mar 18, 2021
Full time
Geoff King at RBW Consulting is looking to recruit level II, Senior, Principal and Senior Principal Statistical Programmer to work for a global CRO recently announced as one of the top places to work by the international publication Forbes. This highly respected CRO pride themselves in their collaborative work culture and social impact spanning over 80 countries worldwide and invite you to become part of this exciting period of growth for the company. Due to continued expansion, we are looking to hire Statistical Programmers at all levels for fully home based vacancies in the UK and Europe to work on multiple therapeutic areas as part of the global full service team or client specific FSP model. You will have the opportunity to lead studies and will be expected to have knowledge of CDISC standards and SDTM/ADaM datasets. Supported by cutting edge technology and a collaborative team of industry experts this organisation gives you the opportunity to work at the forefront of the pharmaceutical industry. Salaries are dependent on experience ranging from £40,000 - £80,000 + additional financial incentives and career paths range from line management to subject matter expert and will be tailored specifically to you. *Main duties & responsibilities:* * Provide experienced technical expertise to develop process methodology for department to meet internal and external clients' needs. * Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. * Provide technical expertise and leadership to the department. * Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. * A crucial aspect is to maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml). * Attend functional meetings and training *Key requirements:* * Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology industries * Knowledge of statistics, programming and/or clinical drug development process * Advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language * Ability to lead teams and projects and capable of managing at a group level * Degree in computer science or related field and 3 years relevant experience A comprehensive job description for your level is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
*Lead CRA * *Home based UK* A fantastic opportunity has arisen for an experienced Clinical Research Associate to work for an ambitious emerging CRO. The role is for a Lead CRA with a real opportunity to progress. This crucial role will require your involvement in initiating the clinical studies set to run across UK and Europe. You will be monitoring on a number of studies in UK with wider travel expected across Europe. To be considered for this position we are looking for someone with significant senior experience which should include management / coordination of the activities, overseeing site visit reports and managing sites. The ideal candidate will need the following experience / skills to be considered: • Previous clinical trial monitoring experience gained within a CRO or Pharmaceutical company 4 + years • Phase I experience is essential • Experience in 2 plus of the following TA's: Oncology, Gene Therapy, Vaccines • Strong communication skills both written and verbal • Proven experience of building relationships with site staff This is an excellent opportunity for someone looking to take the next step in their career and join an innovative, ambitious company where your hard work and commitment will be rewarded. You can expect and competitive salary and benefits package. This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be. [](mailto:)
Mar 18, 2021
Full time
*Lead CRA * *Home based UK* A fantastic opportunity has arisen for an experienced Clinical Research Associate to work for an ambitious emerging CRO. The role is for a Lead CRA with a real opportunity to progress. This crucial role will require your involvement in initiating the clinical studies set to run across UK and Europe. You will be monitoring on a number of studies in UK with wider travel expected across Europe. To be considered for this position we are looking for someone with significant senior experience which should include management / coordination of the activities, overseeing site visit reports and managing sites. The ideal candidate will need the following experience / skills to be considered: • Previous clinical trial monitoring experience gained within a CRO or Pharmaceutical company 4 + years • Phase I experience is essential • Experience in 2 plus of the following TA's: Oncology, Gene Therapy, Vaccines • Strong communication skills both written and verbal • Proven experience of building relationships with site staff This is an excellent opportunity for someone looking to take the next step in their career and join an innovative, ambitious company where your hard work and commitment will be rewarded. You can expect and competitive salary and benefits package. This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be. [](mailto:)
Geoff King at RBW Consulting has engaged with one of the world's recognised specialist biometrics CROs supporting global pharma, biotech and medical device companies as they embark on an exciting period of growth. Due to organic growth, this company now require multiple Senior Statistical Programmers who share the company values of providing a high quality, professional service in a flexible and rewarding work environment. Having recently won a prestigious national award for innovation, this company pride themselves on their renowned team of biometrics experts pushing the boundaries of what biometrics can provide to the pharmaceutical industry and actively encourage input to improve processes and SOPs. Supported by an award winning in-house system, this is position is able to be worked remotely within the UK. *Main duties & responsibilities:* * CDISC SDTM & ADaM mapping and programming * Project lead on assigned studies * Lead role in the development and implementation of new systems, processes and SOPs * Providing expert advice and technical expertise to internal and external stakeholders * Production of analysis datasets and tables, listings & figures * Provide training and mentoring Statistical Programming staff *Key requirements:* * Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology industries * Proven track record in leading study teams * Subject Matter Expert * Commercial awareness, budgeting, resource allocation etc * Advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language * Degree in computer science or related field and 5+ years relevant experience A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Mar 17, 2021
Full time
Geoff King at RBW Consulting has engaged with one of the world's recognised specialist biometrics CROs supporting global pharma, biotech and medical device companies as they embark on an exciting period of growth. Due to organic growth, this company now require multiple Senior Statistical Programmers who share the company values of providing a high quality, professional service in a flexible and rewarding work environment. Having recently won a prestigious national award for innovation, this company pride themselves on their renowned team of biometrics experts pushing the boundaries of what biometrics can provide to the pharmaceutical industry and actively encourage input to improve processes and SOPs. Supported by an award winning in-house system, this is position is able to be worked remotely within the UK. *Main duties & responsibilities:* * CDISC SDTM & ADaM mapping and programming * Project lead on assigned studies * Lead role in the development and implementation of new systems, processes and SOPs * Providing expert advice and technical expertise to internal and external stakeholders * Production of analysis datasets and tables, listings & figures * Provide training and mentoring Statistical Programming staff *Key requirements:* * Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology industries * Proven track record in leading study teams * Subject Matter Expert * Commercial awareness, budgeting, resource allocation etc * Advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language * Degree in computer science or related field and 5+ years relevant experience A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Our Client, a leading global organisation within the life sciences, is looking to recruit a *Global Data Manager (remote) *to join the team. *Who you are* You will have already gained experience working as a Data Manager and be looking for career development, supporting a top pharmaceutical company. Ideally you will also be an undergraduate with a Life Science degree. *Duties will typically involve* * Serving as primary client liaison for Data Management issues with both client studies and external vendor contacts * Tracking milestones and tasks for assigned projects * Ensuring timely completion of all project status reporting * Interfacing with team members across all departments as needed * Providing study specific, including protocol training, to extended Data Management team members as appropriate * Attending client kick off and investigator meetings as required * Ensure QC steps are implemented so quality deliverables are provided * Ensuring project deliverables are achieved in terms of timelines and quality * Setting timelines for study team * Identifying and negating study issues early in the start-up process * Oversight of performing hands on data management tasks from start-up through database lock * Providing system demonstrations as needed to study team members * External vendor management including creating Data Transfer Agreements *Competencies / Skills required* * Excellent written and oral communication skills. * Proficiency in at least one EDC system required * Experience working in industry standard Clinical Data Management system(s) * Experience with all steps within the Data Management lifecycle * Experience as primary representative of Clinical Data Management project team * Proven history of successful interaction with internal and external clients and an understanding of related functions * Basic knowledge of CDISC/SDTM and SAS Our Client offers a competitive salary, with a comprehensive range of benefits. As they continue to expand, there will be career opportunities on a truly global scale. For further information please contact Louise Clark (0)
Mar 17, 2021
Full time
Our Client, a leading global organisation within the life sciences, is looking to recruit a *Global Data Manager (remote) *to join the team. *Who you are* You will have already gained experience working as a Data Manager and be looking for career development, supporting a top pharmaceutical company. Ideally you will also be an undergraduate with a Life Science degree. *Duties will typically involve* * Serving as primary client liaison for Data Management issues with both client studies and external vendor contacts * Tracking milestones and tasks for assigned projects * Ensuring timely completion of all project status reporting * Interfacing with team members across all departments as needed * Providing study specific, including protocol training, to extended Data Management team members as appropriate * Attending client kick off and investigator meetings as required * Ensure QC steps are implemented so quality deliverables are provided * Ensuring project deliverables are achieved in terms of timelines and quality * Setting timelines for study team * Identifying and negating study issues early in the start-up process * Oversight of performing hands on data management tasks from start-up through database lock * Providing system demonstrations as needed to study team members * External vendor management including creating Data Transfer Agreements *Competencies / Skills required* * Excellent written and oral communication skills. * Proficiency in at least one EDC system required * Experience working in industry standard Clinical Data Management system(s) * Experience with all steps within the Data Management lifecycle * Experience as primary representative of Clinical Data Management project team * Proven history of successful interaction with internal and external clients and an understanding of related functions * Basic knowledge of CDISC/SDTM and SAS Our Client offers a competitive salary, with a comprehensive range of benefits. As they continue to expand, there will be career opportunities on a truly global scale. For further information please contact Louise Clark (0)
*Senior Clinical Project Manager * *Home based UK * In support of a small but expanding CRO I am currently searching for an experienced Clinical Research professional looking to develop their career for an ambitious organisation. My client are looking to increase their headcount and add to their successful team with a dynamic and committed individual with Clinical Project Management experience. As Senior Clinical Project Manager, you will take responsibility for managing clinical studies, with key responsibilities to include: * Act as the primary point of contact and liaison with sponsors ensuring excellent customer service is delivered * Prepare and review protocols and other study related documents * Prepare submission documents for the Ethics Committee and regulatory authorities * Report projects according to client specific procedures or the specific SOPs * Supervise and lead study team to contribute towards efficient management of trials *Candidate Profile:* * A minimum of 5years Project Management experience from a CRO, Pharmaceutical or biotechnology company * BSc degree in life sciences, with MSc or PhD preferable * Phase I experience is essential * TA experience in 2 or more of the following: Oncology, Vaccines, Gene Therapy * Ambitious, with a drive to progress and develop within a company This is one of several positions in the field of clinical research that I am currently working on, so please do get in touch for a confidential discussion on your options for progression. Please contact Grace Ticehurst on or click Apply Now to submit your CV. *Keywords:* Project management | project manager | clinical project manager | Oncology | Rare Diseases | clinical research | clinical trials | CRO | progression | UK |
Mar 17, 2021
Full time
*Senior Clinical Project Manager * *Home based UK * In support of a small but expanding CRO I am currently searching for an experienced Clinical Research professional looking to develop their career for an ambitious organisation. My client are looking to increase their headcount and add to their successful team with a dynamic and committed individual with Clinical Project Management experience. As Senior Clinical Project Manager, you will take responsibility for managing clinical studies, with key responsibilities to include: * Act as the primary point of contact and liaison with sponsors ensuring excellent customer service is delivered * Prepare and review protocols and other study related documents * Prepare submission documents for the Ethics Committee and regulatory authorities * Report projects according to client specific procedures or the specific SOPs * Supervise and lead study team to contribute towards efficient management of trials *Candidate Profile:* * A minimum of 5years Project Management experience from a CRO, Pharmaceutical or biotechnology company * BSc degree in life sciences, with MSc or PhD preferable * Phase I experience is essential * TA experience in 2 or more of the following: Oncology, Vaccines, Gene Therapy * Ambitious, with a drive to progress and develop within a company This is one of several positions in the field of clinical research that I am currently working on, so please do get in touch for a confidential discussion on your options for progression. Please contact Grace Ticehurst on or click Apply Now to submit your CV. *Keywords:* Project management | project manager | clinical project manager | Oncology | Rare Diseases | clinical research | clinical trials | CRO | progression | UK |
