Global Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based in Europe)

IQVIA LLC; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

IQVIA is seeking a Senior Global Trial Manager to join our Single Sponsor Department. As a core Clinical Trial Team member, you will lead global studies, collaborate across functions, and drive late‑phase programs to meet timelines, budgets and quality standards.

You will oversee operational setup and maintenance, risk and issue management, regulatory documentation, CRO oversight, and budget planning, while engaging global stakeholders.

Qualifications

• Advanced degree in life sciences or healthcare.
• Minimum 5 years' experience in planning, executing and reporting global clinical trials in a pharmaceutical company or CRO, preferably including at least 2 years managing Real World Evidence (RWE) or global late-phase studies.
• Experience working in global, cross-functional matrix teams and building effective relationships with internal and external stakeholders.
• Ability to manage multiple studies or programs of work in parallel, consistently delivering to time, budget and quality expectations.
• Strong planning, communication, influencing, problem-solving and organisational skills, with the ability to work independently and manage ambiguity and change.
• A quality and compliance mindset, high attention to detail and the confidence to speak up, challenge constructively and drive issues to resolution.
• Experience contributing to relevant clinical study documents (e.g. protocols, PSURs, DSURs, regulatory submissions)

Responsibilities

• Plan, coordinate and oversee assigned Medical Affairs activities from operational set-up through maintenance, reporting and closure, ensuring deliverables and milestones are achieved on time and to the required quality standards.
• Act as the operational point of contact for assigned work and build productive relationships with global stakeholders, including Medical Affairs teams, study teams, investigators, external partners, reviewers, governance groups, CROs and other vendors.
• Develop, coordinate, review and maintain relevant study, program, submission and regulatory documentation, ensuring required inputs, approvals, decisions and records are complete and available in the appropriate systems.
• Coordinate the collection and timely completion of Global Medical Affairs inputs for program-level and safety documents, including DSURs, PSURs, Investigator Brochures, Addenda to Clinical Overviews and annual regulatory reports, where applicable.
• Organise and support kick-off, strategy, scientific review, governance and comment-resolution meetings, including preparation of pre-reads, agendas, supporting documentation, minutes, decisions and follow-up actions.
• Manage and maintain accurate operational information, trackers, panels, delegations, study or program status, metrics and reporting in relevant systems and databases.
• Plan and monitor budgets and resources, including investigational product or Post-Study Drug Supply forecasts where relevant, identifying impacts and escalating material changes for approval.
• Support the selection, contracting and oversight of CROs and third-party vendors, and monitor the performance of external partners where applicable.
• Identify, assess and manage operational, quality, compliance, GCP and delivery risks and issues; develop mitigation plans, elevate appropriately and support the timely completion of corrective and preventive actions.
• Monitor adherence to SOPs, working practices, GCP and other applicable requirements, maintaining audit and inspection readiness and supporting audit preparation, enquiries and corrective actions.
• Track assigned activities and outstanding items through to final resolution, ensuring timely execution, accurate reporting and effective communication of progress, decisions and dependencies.
• Contribute to process simplification, operational excellence, knowledge sharing and continuous improvement, promoting a strong culture of quality, integrity, collaboration and compliance.

Skills

Global trial management

Stakeholder management

Budget planning

Cross-functional collaboration

GCP compliance

Education

Advanced degree in life sciences or healthcare

Job description

We are looking for a Senior Global Trial Manager to join our Single Sponsor Department. As a core Clinical Trial Team (CTT) member, you'll lead critical aspects of global studies and collaborate across functions to drive success, delivering late-phase clinical trials that meet timelines, budgets, and quality standards. This is a unique opportunity to specialize in one or more for the following role pathways:

Role Pathways

• Scientific Review Committee (SRC)
• Non-Interventional Studies (NIS)
• Managed Access Programs (MAP)
• Investigator-Initiated Trials (IITs)
• Research Collaborations (RCs)
• Program Level Documents (PLD)

Specific responsibilities will depend on the role pathway for which you are selected. Across all pathways, you will be expected to bring strong planning, stakeholder management, data accuracy, risk management and a continuous-improvement mindset.

• Plan, coordinate and oversee assigned Medical Affairs activities from operational set-up through maintenance, reporting and closure, ensuring deliverables and milestones are achieved on time and to the required quality standards.
• Act as the operational point of contact for assigned work and build productive relationships with global stakeholders, including Medical Affairs teams, study teams, investigators, external partners, reviewers, governance groups, CROs and other vendors.
• Develop, coordinate, review and maintain relevant study, program, submission and regulatory documentation, ensuring required inputs, approvals, decisions and records are complete and available in the appropriate systems.
• Coordinate the collection and timely completion of Global Medical Affairs inputs for program-level and safety documents, including DSURs, PSURs, Investigator Brochures, Addenda to Clinical Overviews and annual regulatory reports, where applicable.
• Organise and support kick-off, strategy, scientific review, governance and comment-resolution meetings, including preparation of pre-reads, agendas, supporting documentation, minutes, decisions and follow-up actions.
• Manage and maintain accurate operational information, trackers, panels, delegations, study or program status, metrics and reporting in relevant systems and databases.
• Plan and monitor budgets and resources, including investigational product or Post-Study Drug Supply forecasts where relevant, identifying impacts and escalating material changes for approval.
• Support the selection, contracting and oversight of CROs and third-party vendors, and monitor the performance of external partners where applicable.
• Identify, assess and manage operational, quality, compliance, GCP and delivery risks and issues; develop mitigation plans, elevate appropriately and support the timely completion of corrective and preventive actions.
• Monitor adherence to SOPs, working practices, GCP and other applicable requirements, maintaining audit and inspection readiness and supporting audit preparation, enquiries and corrective actions.
• Track assigned activities and outstanding items through to final resolution, ensuring timely execution, accurate reporting and effective communication of progress, decisions and dependencies.
• Contribute to process simplification, operational excellence, knowledge sharing and continuous improvement, promoting a strong culture of quality, integrity, collaboration and compliance.

Qualifications

• Advanced degree in life sciences or healthcare
• Minimum 5 years' experience in planning, executing and reporting global clinical trials in a pharmaceutical company or CRO, preferably including at least 2 years managing Real World Evidence (RWE) or global late-phase studies (e.g. PASS, PAES, NIS), or relevant equivalent Medical Affairs experience (dependent on role pathway).
• Experience working in global, cross-functional matrix teams and building effective relationships with internal and external stakeholders.
• Ability to manage multiple studies or programs of work in parallel, consistently delivering to time, budget and quality expectations.
• Strong planning, communication, influencing, problem-solving and organisational skills, with the ability to work independently and manage ambiguity and change.
• A quality and compliance mindset, high attention to detail and the confidence to speak up, challenge constructively and drive issues to resolution.
• Experience contributing to relevant clinical study documents (e.g. protocols, PSURs, DSURs, regulatory submissions)

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 https://jobs.iqvia.com . IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.