Senior Global Trial Manager, Late Phase Studies (Home-Based Europe)
iqvia · Madrid
Descripcion del puesto
About the role
A Senior Global Trial Manager is sought for IQVIA's Single Sponsor Department, working from home in Europe (Madrid listed). As a core Clinical Trial Team member, you will lead key aspects of global late-phase studies and collaborate across functions to deliver trials on time, within budget and to quality standards. The role can follow one of several pathways: Scientific Review Committee (SRC), Non-Interventional Studies (NIS), Managed Access Programs (MAP), Investigator-Initiated Trials (IITs), Research Collaborations (RCs) or Program Level Documents (PLD).
Key responsibilities
- Plan, coordinate and oversee Medical Affairs activities from set-up through maintenance, reporting and closure.
- Act as operational point of contact for assigned work and build relationships with Medical Affairs, study teams, investigators, external partners, reviewers, governance groups, CROs and vendors.
- Maintain study, program, submission and regulatory documentation in the appropriate systems.
- Coordinate Global Medical Affairs inputs for program-level and safety documents such as DSURs, PSURs, Investigator Brochures and annual regulatory reports.
- Organise kick-off, strategy, scientific review, governance and comment-resolution meetings, including pre-reads, agendas, minutes and follow-up actions.
- Manage operational trackers, status, metrics and reporting, and plan and monitor budgets and resources.
- Support CRO and vendor selection, contracting and performance monitoring.
- Identify and manage operational, quality, compliance and GCP risks, and maintain audit and inspection readiness.
Required profile
- Advanced degree in life sciences or healthcare.
- At least 5 years' experience planning, executing and reporting global clinical trials in a pharma company or CRO, preferably including 2 years managing RWE or global late-phase studies (PASS, PAES, NIS) or equivalent Medical Affairs experience depending on pathway.
- Experience in global, cross-functional matrix teams and with internal and external stakeholders.
- Ability to manage multiple studies or programs in parallel to time, budget and quality expectations.
- Experience contributing to clinical study documents such as protocols, PSURs, DSURs and regulatory submissions.
The role is not eligible for UK visa sponsorship, and only candidates based in the listed location are considered.
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Publicado hace 8 horas
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iqvia
Madrid