Job Purpose Location: home-based, UK, Slovakia, Poland, Bulgaria The Associate Director Senior Study Lead is the leader of the cross-functional clinical trial team (CTT), who guides planning and management of the assigned clinical study/studies end-to-end to achieve objectives. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT. Oversees budget and people allocation within assigned study/studies. Contributes in promoting operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs. Key accountabilities Executes and delivers clinical studies; guides planning and decision making at study-level Acts as the CTT product owner with clear and focused duties and responsibilities per the agile ways of working Active member of a Clinical Operations community within the study leadership organization Promotes operational excellence in the shared development of global clinical study protocol(s), clinical study report(s), and other study-related documents Deliverables Patient recruitment, clinical data, study documentation and study reports Efficient delivery of the protocol, ICF, Monitoring Plan, and CSR in quality and on time Cost effective management of study budget Proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT Key expertise and skillset Bachelor's degree in life sciences/healthcare (or clinically relevant degree) is required. Advanced degree is strongly preferred. 4 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV of standard to high complexity and priority. 3 years of recent contribution to and accomplishment in all aspects of conducting clinical studies of standard to high complexity and priority (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities Experience in managing people globally in a complex matrix environment preferred Management of virtual teams. Proven ability and strong experience leading teams and building capabilities Experience in developing effective working relationships with internal and external stakeholders Excellent communicator and presenter (oral and written); ability to communicate at all levels Excellent organization and prioritization Strong negotiation and conflict resolution skills and enterprise mindset, demonstrated by ability to drive for aligned solutions Fluent English, oral and written Location: Home-based This role is not eligible for UK visa sponsorship IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Sep 04, 2025
Full time
Job Purpose Location: home-based, UK, Slovakia, Poland, Bulgaria The Associate Director Senior Study Lead is the leader of the cross-functional clinical trial team (CTT), who guides planning and management of the assigned clinical study/studies end-to-end to achieve objectives. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT. Oversees budget and people allocation within assigned study/studies. Contributes in promoting operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs. Key accountabilities Executes and delivers clinical studies; guides planning and decision making at study-level Acts as the CTT product owner with clear and focused duties and responsibilities per the agile ways of working Active member of a Clinical Operations community within the study leadership organization Promotes operational excellence in the shared development of global clinical study protocol(s), clinical study report(s), and other study-related documents Deliverables Patient recruitment, clinical data, study documentation and study reports Efficient delivery of the protocol, ICF, Monitoring Plan, and CSR in quality and on time Cost effective management of study budget Proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT Key expertise and skillset Bachelor's degree in life sciences/healthcare (or clinically relevant degree) is required. Advanced degree is strongly preferred. 4 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV of standard to high complexity and priority. 3 years of recent contribution to and accomplishment in all aspects of conducting clinical studies of standard to high complexity and priority (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities Experience in managing people globally in a complex matrix environment preferred Management of virtual teams. Proven ability and strong experience leading teams and building capabilities Experience in developing effective working relationships with internal and external stakeholders Excellent communicator and presenter (oral and written); ability to communicate at all levels Excellent organization and prioritization Strong negotiation and conflict resolution skills and enterprise mindset, demonstrated by ability to drive for aligned solutions Fluent English, oral and written Location: Home-based This role is not eligible for UK visa sponsorship IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study startup throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Sponsor Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality. Responsabilities: Participate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable sponsor controlled documents. Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time. Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations. Conduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirements Attend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationships Review a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns • Collaborate with sponsor CPM and sponsor Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met. Manage study start up in collaboration with internal and external project teams (e.g. sponsor Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues. Act as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from CRO, IRB/IECs/RAs, Third Party Vendors and sites. Provide routine updates to the internal project team on study status/issues Manages the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collection Provide direction and support to the CPM in ensuring consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate. Manages consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate Works cross-functionally with other sponsor departments (Clinical Supplies, Quality Assurance, Regulatory Affairs) to ensure all clinical trial activities performed by sponsor as a Sponsor are performed according to study requirements and timelines. Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, protocol, informed consent documents (master and/or site specific), budgets, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals, case report form development and training materials Execute and/or deliver trial specific training as required Review of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studies Contribute to the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Support study team with site selection while optimizing start-up processes to ensure efficient start-up timelines are met. Attend and present at Investigator Meetings on Clinical Operations topics, as required May oversee the accurate, timely, and complete tracking of laboratory samples May represent Clinical Operations in cross-functional initiatives (e.g., start-up, continued process improvements with CROs). Contribute to the development and/or participate in the review of sponsor SOPs, Work Instructions and team policies Contribute to preparation of investigator newsletters or email newsflashes. Supports the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to CAPAs as required Oversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate Accountable for ensuring all study deliverables and milestones are met with quality and within timelines Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets Provides support/escalation point for direct reports as needed Profile: At least 8 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CRO Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus Experience with start-up and initiation of clinical trial sites Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required Ability to communicate and coordinate activities with the internal team, clinical sites and vendors Proactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervision Ability to work independently Experience presenting high level presentations, both orally and in writing Knowledge of and experience with immunotherapies and/or Oncology At least 2 years of on-site monitoring experience IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Sep 04, 2025
Full time
The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study startup throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Sponsor Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality. Responsabilities: Participate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable sponsor controlled documents. Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time. Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations. Conduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirements Attend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationships Review a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns • Collaborate with sponsor CPM and sponsor Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met. Manage study start up in collaboration with internal and external project teams (e.g. sponsor Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues. Act as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from CRO, IRB/IECs/RAs, Third Party Vendors and sites. Provide routine updates to the internal project team on study status/issues Manages the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collection Provide direction and support to the CPM in ensuring consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate. Manages consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate Works cross-functionally with other sponsor departments (Clinical Supplies, Quality Assurance, Regulatory Affairs) to ensure all clinical trial activities performed by sponsor as a Sponsor are performed according to study requirements and timelines. Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, protocol, informed consent documents (master and/or site specific), budgets, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals, case report form development and training materials Execute and/or deliver trial specific training as required Review of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studies Contribute to the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Support study team with site selection while optimizing start-up processes to ensure efficient start-up timelines are met. Attend and present at Investigator Meetings on Clinical Operations topics, as required May oversee the accurate, timely, and complete tracking of laboratory samples May represent Clinical Operations in cross-functional initiatives (e.g., start-up, continued process improvements with CROs). Contribute to the development and/or participate in the review of sponsor SOPs, Work Instructions and team policies Contribute to preparation of investigator newsletters or email newsflashes. Supports the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to CAPAs as required Oversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate Accountable for ensuring all study deliverables and milestones are met with quality and within timelines Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets Provides support/escalation point for direct reports as needed Profile: At least 8 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CRO Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus Experience with start-up and initiation of clinical trial sites Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required Ability to communicate and coordinate activities with the internal team, clinical sites and vendors Proactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervision Ability to work independently Experience presenting high level presentations, both orally and in writing Knowledge of and experience with immunotherapies and/or Oncology At least 2 years of on-site monitoring experience IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Global Clinical Project Manager - Vendor Management Expert - Single Sponsor (Novartis) Are you an experienced Vendor Management professional looking to make an impact in global clinical trials? We are seeking a Global Clinical Project Manager - Vendor Management Expert to join our Single Sponsor Department, dedicated exclusively to Novartis. In this role, you 'll become an expert in Vendor Management for global clinical trials across all phases (Phase I-IV), ensuring seamless execution from study start-up through close-out. What We're Looking For To excel in this role, you should bring: Global Clinical Project Management experience Strong Vendor Management expertise: Central lab, eCOA, IRT, ECG, Imaging, Ancillaries and/or Patient Recruitment & Retention with experience in global clinical trials. (must have experience managing at least 2 of these vendors) Deep understanding of clinical operations processes and vendor service categories. Excellent project management skills to drive efficiency and collaboration Strong communication and influencing abilities to partner effectively across functions. Proven ability to manage risk and performance issues in a fast-paced environment What You'll Do As a Global Clinical Project Manager - Vendor Management Expert, you will be responsible for ensuring vendor deliverables are met with quality and efficiency at the trial level. Your key responsibilities include: Vendor Oversight & Coordination - Manage vendor activities across the study lifecycle, ensuring timely and high-quality deliverables. Study Start-Up Support - Oversee vendor deliverables during study initiation, ensuring smooth onboarding and activation. Risk & Performance Management - Track vendor performance, identify risks, and escalate issues as needed. Site Readiness & Activation - Drive vendor activities to support site activations and ensure study milestones are met. Study Close-Out - Coordinate vendor deliverables that support Database Lock and study closure. What You'll Deliver Vendor service excellence at the study level Vendor onboarding and performance tracking KPI (Key Performance Indicator) and KQI (Key Quality Indicator) dashboards to monitor vendor effectiveness Site readiness monitoring and documentation Risk mapping with contingency planning Vendor cost control and oversight Please note this role is not eligible for the UK visa sponsorship. This is an exciting opportunity to play a critical role in global clinical trials, ensuring vendor excellence and operational success. If you're ready to take on a high-impact role with a leading sponsor, we'd love to hear from you! IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Sep 04, 2025
Full time
Global Clinical Project Manager - Vendor Management Expert - Single Sponsor (Novartis) Are you an experienced Vendor Management professional looking to make an impact in global clinical trials? We are seeking a Global Clinical Project Manager - Vendor Management Expert to join our Single Sponsor Department, dedicated exclusively to Novartis. In this role, you 'll become an expert in Vendor Management for global clinical trials across all phases (Phase I-IV), ensuring seamless execution from study start-up through close-out. What We're Looking For To excel in this role, you should bring: Global Clinical Project Management experience Strong Vendor Management expertise: Central lab, eCOA, IRT, ECG, Imaging, Ancillaries and/or Patient Recruitment & Retention with experience in global clinical trials. (must have experience managing at least 2 of these vendors) Deep understanding of clinical operations processes and vendor service categories. Excellent project management skills to drive efficiency and collaboration Strong communication and influencing abilities to partner effectively across functions. Proven ability to manage risk and performance issues in a fast-paced environment What You'll Do As a Global Clinical Project Manager - Vendor Management Expert, you will be responsible for ensuring vendor deliverables are met with quality and efficiency at the trial level. Your key responsibilities include: Vendor Oversight & Coordination - Manage vendor activities across the study lifecycle, ensuring timely and high-quality deliverables. Study Start-Up Support - Oversee vendor deliverables during study initiation, ensuring smooth onboarding and activation. Risk & Performance Management - Track vendor performance, identify risks, and escalate issues as needed. Site Readiness & Activation - Drive vendor activities to support site activations and ensure study milestones are met. Study Close-Out - Coordinate vendor deliverables that support Database Lock and study closure. What You'll Deliver Vendor service excellence at the study level Vendor onboarding and performance tracking KPI (Key Performance Indicator) and KQI (Key Quality Indicator) dashboards to monitor vendor effectiveness Site readiness monitoring and documentation Risk mapping with contingency planning Vendor cost control and oversight Please note this role is not eligible for the UK visa sponsorship. This is an exciting opportunity to play a critical role in global clinical trials, ensuring vendor excellence and operational success. If you're ready to take on a high-impact role with a leading sponsor, we'd love to hear from you! IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Job Overview Provide oversight and leadership to Senior Global Trial managers (SGTMs) for project productivity, delivery and quality resulting in strong financial performance and customer satisfaction. Work with Clinical teams to focus on leveraging deep therapeutic expertise and IQVIA solutions to drive operational excellence and strategic leadership with our customers. Direct and manage an assigned team of clinical leads who lead or support studies or programs to make sure quality, time and budget deliverables are met to the Sponsor's satisfaction and in accordance with Standard Operating Procedures (SOPs), policies and practices. Ensure Clinical leads are trained and individual development is aligned and in place to meet project and organizational needs. Attract, develop and retain talent. Essential Functions • Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans). Ensure all Clinical Leads (CLs) obtain Fundamental Good Clinical Practices (GCP) accreditation during a two year cycle. • Actively engage with SGTMs to review project performance and deliverables. Address performance issues and/or escalations by working to create action/recovery plans. Ensure compliance to the Clinical Leads (CL) metrics dashboard of all direct reports. Foster an environment where lessons learned are shared within the team. • Ensure compliance on the overall Risk Management process including risks that are escalating into issues. Work with SGTMs on identification of risks that can lead to processes improvement/standardization across the organization. • Ensure compliance to quality management processes that apply to all projects. Support quality initiatives and ensure quality metrics are met at all times. • Mentor SGTMs to manage clinical aspects of Project Finances, Support to understand the scope of clinical delivery and create plans to deliver against this scope and to monitor and manage changes against baseline and identify additional service opportunities or out of scope work. • Coach SGTMs to identify Out of Scope items, discuss impact and proactively suggest remediation plans when considering risks/delays and to determine appropriate action. Discuss and promote proactive identification of milestone risks by SGTMs • Actively review project level clinical metrics with SGTMs to ensure compliance and accuracy of data. Support SGTMs during Project Review Meetings . Ensure compliance to all critical data fields within Project Management systems/ applicable trackers. Coach SGTMs on running and reviewing various project reports • Resourcing and Talent planning of the SGTM team. Manage the team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance as well as project related trainings. • Conduct progress reviews and evaluations in addition to create contingency plans to mitigate project, program-level and enterprise risks. • Mentor SGTMs for further development and ensure they follow an Individual development plan. Qualifications • Bachelor's Degree Bachelor's Degree in life sciences or related field required Req • Requires 10 years of clinical research experience including 6 years leadership experience, multi-regional and global focus or equivalent combination of education, training and experience. • Requires broad management knowledge to lead cross-regional teams, and well as the ability to influence others outside of own job area regarding policies, procedures, and goals. • Knowledge of clinical trials - In depth knowledge and skill in applying, applicable clinical research regulatory requirements i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Strong understanding of the Clinical Research Industry and the relevant environments in which it operates.; • People Management - Proven ability to manage a team and work alongside others in a global environment to deliver results whilst meeting quality and timeline metrics. Provides others with a clear direction, delegates work appropriately and fairly, motivates and empowers others, monitors/manages performance and provides feedback and coaching, recruits, develops and retains staff of a high caliber. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues • Collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences. Ability to establish and maintain effective working relationships with coworkers, managers and clients. • Leadership - Ability to successfully manage competing priorities. Excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal stakeholders and customers as well as negotiate solutions. Good judgment and decision making skills. • Organization - Strong presentation skills. Strong organizational and problem-solving skills. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving. Strong understanding of other IQVIA functions and their inter-relationship with Project Support Units. • Communication - Excellent communication skills, including good command of English language. • Results Oriented - Demonstrated ability to deliver results to the appropriate quality and timeline metrics. • IT Skills - Strong software and computer skills, including Microsoft Office applications. • IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation, Ownership). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Sep 04, 2025
Full time
Job Overview Provide oversight and leadership to Senior Global Trial managers (SGTMs) for project productivity, delivery and quality resulting in strong financial performance and customer satisfaction. Work with Clinical teams to focus on leveraging deep therapeutic expertise and IQVIA solutions to drive operational excellence and strategic leadership with our customers. Direct and manage an assigned team of clinical leads who lead or support studies or programs to make sure quality, time and budget deliverables are met to the Sponsor's satisfaction and in accordance with Standard Operating Procedures (SOPs), policies and practices. Ensure Clinical leads are trained and individual development is aligned and in place to meet project and organizational needs. Attract, develop and retain talent. Essential Functions • Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans). Ensure all Clinical Leads (CLs) obtain Fundamental Good Clinical Practices (GCP) accreditation during a two year cycle. • Actively engage with SGTMs to review project performance and deliverables. Address performance issues and/or escalations by working to create action/recovery plans. Ensure compliance to the Clinical Leads (CL) metrics dashboard of all direct reports. Foster an environment where lessons learned are shared within the team. • Ensure compliance on the overall Risk Management process including risks that are escalating into issues. Work with SGTMs on identification of risks that can lead to processes improvement/standardization across the organization. • Ensure compliance to quality management processes that apply to all projects. Support quality initiatives and ensure quality metrics are met at all times. • Mentor SGTMs to manage clinical aspects of Project Finances, Support to understand the scope of clinical delivery and create plans to deliver against this scope and to monitor and manage changes against baseline and identify additional service opportunities or out of scope work. • Coach SGTMs to identify Out of Scope items, discuss impact and proactively suggest remediation plans when considering risks/delays and to determine appropriate action. Discuss and promote proactive identification of milestone risks by SGTMs • Actively review project level clinical metrics with SGTMs to ensure compliance and accuracy of data. Support SGTMs during Project Review Meetings . Ensure compliance to all critical data fields within Project Management systems/ applicable trackers. Coach SGTMs on running and reviewing various project reports • Resourcing and Talent planning of the SGTM team. Manage the team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance as well as project related trainings. • Conduct progress reviews and evaluations in addition to create contingency plans to mitigate project, program-level and enterprise risks. • Mentor SGTMs for further development and ensure they follow an Individual development plan. Qualifications • Bachelor's Degree Bachelor's Degree in life sciences or related field required Req • Requires 10 years of clinical research experience including 6 years leadership experience, multi-regional and global focus or equivalent combination of education, training and experience. • Requires broad management knowledge to lead cross-regional teams, and well as the ability to influence others outside of own job area regarding policies, procedures, and goals. • Knowledge of clinical trials - In depth knowledge and skill in applying, applicable clinical research regulatory requirements i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Strong understanding of the Clinical Research Industry and the relevant environments in which it operates.; • People Management - Proven ability to manage a team and work alongside others in a global environment to deliver results whilst meeting quality and timeline metrics. Provides others with a clear direction, delegates work appropriately and fairly, motivates and empowers others, monitors/manages performance and provides feedback and coaching, recruits, develops and retains staff of a high caliber. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues • Collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences. Ability to establish and maintain effective working relationships with coworkers, managers and clients. • Leadership - Ability to successfully manage competing priorities. Excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal stakeholders and customers as well as negotiate solutions. Good judgment and decision making skills. • Organization - Strong presentation skills. Strong organizational and problem-solving skills. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving. Strong understanding of other IQVIA functions and their inter-relationship with Project Support Units. • Communication - Excellent communication skills, including good command of English language. • Results Oriented - Demonstrated ability to deliver results to the appropriate quality and timeline metrics. • IT Skills - Strong software and computer skills, including Microsoft Office applications. • IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation, Ownership). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Job overview Are you a Clinical (Project) IRT Manager with a passion for vendor excellence and study startup success? We're looking for a Vendor Startup Manager (VSM) to join our Single Sponsor Department, dedicated exclusively to Novartis. In this role, you'll bring technical expertise to accelerate vendor service delivery during the critical startup phase of global clinical trials. What We're Looking For To thrive in this role, you'll bring: Strong vendor management skills and deep knowledge of clinical trial startup processes Strategic thinking and the ability to assess risk and implement contingency plans Experience with vendor contracting, budgeting, and onboarding Excellent communication and collaboration skills across internal and external stakeholders Hands-on experience with tools like IRT, UAT (User Acceptance Testing) and UVP (Unified Vendor Portal) What You'll Do As a Vendor Startup Manager, you'll be the go-to expert for vendor service categories during study startup. Your key responsibilities include: Protocol & Specification Review - Ensure vendor input is reflected in final study specs Study Specification Worksheet (SSW) - Support vendor selection and bid process Vendor Kick-Off & Onboarding - Lead meetings and ensure readiness for DB go-live Budget & Contract Support - Review quotes and assist with negotiations Risk Mapping & Contingency Planning - Proactively identify and mitigate startup risks Performance Oversight - Monitor vendor delivery and escalate issues as needed UAT Execution - Conduct robust testing and design for IRT systems Collaboration - Partner with TVMs, VALs, Procurement, and QA to drive startup success What You'll Deliver Accelerated and high-quality vendor startup Vendor risk maps and performance tracking Audit-ready documentation and compliance Continuous improvement and best practice sharing Expertise in key service categories like Central Labs, Imaging, and Diagnostics This is a high-impact opportunity to shape the success of global clinical trials from day one. If you're ready to lead vendor startup excellence in a dynamic, sponsor-focused environment-we'd love to hear from you! This position is not eligible for UK VISA Sponsorship IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Sep 04, 2025
Full time
Job overview Are you a Clinical (Project) IRT Manager with a passion for vendor excellence and study startup success? We're looking for a Vendor Startup Manager (VSM) to join our Single Sponsor Department, dedicated exclusively to Novartis. In this role, you'll bring technical expertise to accelerate vendor service delivery during the critical startup phase of global clinical trials. What We're Looking For To thrive in this role, you'll bring: Strong vendor management skills and deep knowledge of clinical trial startup processes Strategic thinking and the ability to assess risk and implement contingency plans Experience with vendor contracting, budgeting, and onboarding Excellent communication and collaboration skills across internal and external stakeholders Hands-on experience with tools like IRT, UAT (User Acceptance Testing) and UVP (Unified Vendor Portal) What You'll Do As a Vendor Startup Manager, you'll be the go-to expert for vendor service categories during study startup. Your key responsibilities include: Protocol & Specification Review - Ensure vendor input is reflected in final study specs Study Specification Worksheet (SSW) - Support vendor selection and bid process Vendor Kick-Off & Onboarding - Lead meetings and ensure readiness for DB go-live Budget & Contract Support - Review quotes and assist with negotiations Risk Mapping & Contingency Planning - Proactively identify and mitigate startup risks Performance Oversight - Monitor vendor delivery and escalate issues as needed UAT Execution - Conduct robust testing and design for IRT systems Collaboration - Partner with TVMs, VALs, Procurement, and QA to drive startup success What You'll Deliver Accelerated and high-quality vendor startup Vendor risk maps and performance tracking Audit-ready documentation and compliance Continuous improvement and best practice sharing Expertise in key service categories like Central Labs, Imaging, and Diagnostics This is a high-impact opportunity to shape the success of global clinical trials from day one. If you're ready to lead vendor startup excellence in a dynamic, sponsor-focused environment-we'd love to hear from you! This position is not eligible for UK VISA Sponsorship IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Job Overview Core member of the Clinical Trial Team (CTT), independently managing all vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Accountable for vendor service delivery at study level. Collaborates closely with the Vendor Start-up Manager (VSM) for selected services (central labs, electronic clinical outcomes assessment/electronic patient reported outcomes (eCOA/ePRO), interactive response technology (IRT), cardiac and respiratory diagnostics, patient recruitment and retention (PR&R), and imaging reading) during study start-up, and leverages effectively their technical and study start-up (SSU) expertise to ensure a timely study start-up. Proactively manages vendor-related risks and potential issues. Implements global vendor strategy and if required, escalates vendor issues to the VSM while keeping Vendor Program Leads informed about risks, issues, and study progress. Oversees vendor compliance at study level. Essential Functions Accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Collaborates with the VSM for the VSM's category specific responsibilities. Responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study. Assigned responsibilities can include but are not limited to: • Close interaction and collaboration with study team lead and study team members during study lifetime • Review of vendor related protocol sections during protocol development • Collaborate with Vendor startup manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion. • Manages interface with vendors in cooperation with vendor partner functions • Quote/proposal review in collaboration with procurement, support contract negotiations, if required • Contributes to the development of vendor contract amendments • Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out • Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial • Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up • Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs • Attends vendor kick-off meeting for VSM supported categories • Optimizing a frontloaded and timely study-start-up process, manages vendor-related activities for DB go live • Performs user-acceptance testing (UAT) for eCOA and IRT • Drives and monitors central vendor-related activities for site activation, compiles Final Protocol Package (FPP) required documents centrally, monitors site activation progress and addresses related issues and risk • Creates and maintains vendor-related risk maps with contingency plan for documentation in FIRST • Manages system and portal user access for vendor, sponsor and site staff, maintain access logs • Uses Unified Vendor Portal (UVP) to manage vendor • Uses Clinical Insights to manage vendors and to achieve site readiness timelines • Plans and tracks supply delivery to sites and return of equipment from sites • Interacts and collaborates with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL) • Acts as escalation point for vendor-related query management • Follow-up with countries and hubs for their vendor-related risks and issues • Document issues identified with vendor oversight/performance in FIRST tool and implements and monitors corrective action Qualifications • Bachelor's Degree Life sciences or related field Req • Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience. Req • Requires 10 years clinical research experience including 6 years of project management experience or equivalent combination of education, training and experience. Req • Knowledge of clinical trials - Knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions. • Proven track record managing complex studies • Very good knowledge of clinical trial design and mapping to supplier requirements • Thorough and technical understanding of specifications for supplier provided services • User Acceptance testing for eCOA and IRT • Site collaboration and site activation • Vendor management; outsourcing, contracting, sourcing, of clinical services • Communication - Strong written and verbal communication skills including good command of English language Strong presentation skills. Requires strong negotiation and customer management skills. • Problem solving - Strong problem solving skills. • Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently. Ability to make decisions, bringing clarity to disparate information to inform actions and drive results. • Organisation - Planning, time management and prioritization skills Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances. • Prioritisation - Ability to handle conflicting priorities. Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project. • Quality - Attention to detail and accuracy in work. • Quality - Results-oriented approach to work delivery and output. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving. • IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint. • Collaboration - Ability to establish and maintain effective working relationships with co-workers, managers and clients. Excellent customer service skills and demonstrated ability to understand customer needs. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues. • Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences Good understanding of other IQVIA functions and their inter-relationship with Project Leadership. • Finances - Good understanding Please note this role is not eligible for the UK visa sponsorship. of project financials including experience managing, contractual obligations and implications. • Audit & inspection readiness and management • Comfort with Ambiguity; Ability to maintain productivity and focus when goals, roles, or processes are not clearly defined. • IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation and Ownership). Please note this role is not eligible for the UK visa sponsorship. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Sep 04, 2025
Full time
Job Overview Core member of the Clinical Trial Team (CTT), independently managing all vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Accountable for vendor service delivery at study level. Collaborates closely with the Vendor Start-up Manager (VSM) for selected services (central labs, electronic clinical outcomes assessment/electronic patient reported outcomes (eCOA/ePRO), interactive response technology (IRT), cardiac and respiratory diagnostics, patient recruitment and retention (PR&R), and imaging reading) during study start-up, and leverages effectively their technical and study start-up (SSU) expertise to ensure a timely study start-up. Proactively manages vendor-related risks and potential issues. Implements global vendor strategy and if required, escalates vendor issues to the VSM while keeping Vendor Program Leads informed about risks, issues, and study progress. Oversees vendor compliance at study level. Essential Functions Accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Collaborates with the VSM for the VSM's category specific responsibilities. Responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study. Assigned responsibilities can include but are not limited to: • Close interaction and collaboration with study team lead and study team members during study lifetime • Review of vendor related protocol sections during protocol development • Collaborate with Vendor startup manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion. • Manages interface with vendors in cooperation with vendor partner functions • Quote/proposal review in collaboration with procurement, support contract negotiations, if required • Contributes to the development of vendor contract amendments • Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out • Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial • Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up • Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs • Attends vendor kick-off meeting for VSM supported categories • Optimizing a frontloaded and timely study-start-up process, manages vendor-related activities for DB go live • Performs user-acceptance testing (UAT) for eCOA and IRT • Drives and monitors central vendor-related activities for site activation, compiles Final Protocol Package (FPP) required documents centrally, monitors site activation progress and addresses related issues and risk • Creates and maintains vendor-related risk maps with contingency plan for documentation in FIRST • Manages system and portal user access for vendor, sponsor and site staff, maintain access logs • Uses Unified Vendor Portal (UVP) to manage vendor • Uses Clinical Insights to manage vendors and to achieve site readiness timelines • Plans and tracks supply delivery to sites and return of equipment from sites • Interacts and collaborates with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL) • Acts as escalation point for vendor-related query management • Follow-up with countries and hubs for their vendor-related risks and issues • Document issues identified with vendor oversight/performance in FIRST tool and implements and monitors corrective action Qualifications • Bachelor's Degree Life sciences or related field Req • Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience. Req • Requires 10 years clinical research experience including 6 years of project management experience or equivalent combination of education, training and experience. Req • Knowledge of clinical trials - Knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions. • Proven track record managing complex studies • Very good knowledge of clinical trial design and mapping to supplier requirements • Thorough and technical understanding of specifications for supplier provided services • User Acceptance testing for eCOA and IRT • Site collaboration and site activation • Vendor management; outsourcing, contracting, sourcing, of clinical services • Communication - Strong written and verbal communication skills including good command of English language Strong presentation skills. Requires strong negotiation and customer management skills. • Problem solving - Strong problem solving skills. • Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently. Ability to make decisions, bringing clarity to disparate information to inform actions and drive results. • Organisation - Planning, time management and prioritization skills Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances. • Prioritisation - Ability to handle conflicting priorities. Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project. • Quality - Attention to detail and accuracy in work. • Quality - Results-oriented approach to work delivery and output. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving. • IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint. • Collaboration - Ability to establish and maintain effective working relationships with co-workers, managers and clients. Excellent customer service skills and demonstrated ability to understand customer needs. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues. • Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences Good understanding of other IQVIA functions and their inter-relationship with Project Leadership. • Finances - Good understanding Please note this role is not eligible for the UK visa sponsorship. of project financials including experience managing, contractual obligations and implications. • Audit & inspection readiness and management • Comfort with Ambiguity; Ability to maintain productivity and focus when goals, roles, or processes are not clearly defined. • IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation and Ownership). Please note this role is not eligible for the UK visa sponsorship. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at