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Freelance Late Phase Clinical Project Manager PASS / Registries
Remote based across EU & UK
Start Date:Immediate
The Role:
We are seeking an experiencedClinical Project Manager (CPM)to lead and managelate-phaseandreal-world evidencestudies, particularlyPASSanddisease/product registries. This role is ideal for a hands-on, proactive leader who thrives in a collaborative environment and has a solid background in non-interventional or observational studies.
Key Responsibilities:
- Manage the planning, execution, and delivery of post-approval clinical studies (PASS, registries) in compliance with GCP, local regulations, and internal SOPs
- Act as the main point of contact for sponsors, vendors, and cross-functional teams
- Develop study documents (protocols, SAPs, CRFs, etc.) in collaboration with medical and regulatory teams
- Oversee timelines, budgets, and resources to ensure successful project delivery
- Support regulatory submissions, ethics applications, and safety reporting processes
- Ensure data quality and study compliance through robust vendor and site management
- Lead project team meetings and provide regular status updates to stakeholders
- Drive continuous improvement and lessons learned across late-phase programs
Requirements:
- Degree in life sciences or related field
- Minimum 4-5 years of clinical project management experience, with a strong focus on late-phase/post-marketing studies
- Demonstrated experience managing PASS, registries, or non-interventional studies
- Solid understanding of real-world evidence generation, GVP, and relevant regulatory frameworks (e.g., EMA PASS guidance)
- Excellent communication, leadership, and stakeholder management skills
- Experience working with CROs, vendors, and multi-country studies preferred
- Fluent in English; additional languages a plus
