We are seeking a Senior TMF Manager to provide strategic leadership and hands-on oversight of the Trial Master File (TMF) across multiple clinical trials. This role is central to ensuring a high-quality, inspection-ready TMF, with a strong focus on eTMF system implementation, governance, and continuous improvement.
Requirements
- Bachelor's degree in Life Sciences or a related field (required)
- 8+ years of clinical research experience, including 5+ years in TMF management
- Proven track record leading eTMF system implementations and migrations
- Experience working with leading eTMF platforms (e.g., Veeva Vault)
- Demonstrated experience supporting FDA and EMA inspections
- Deep knowledge of ICH-GCP, TMF regulations, and clinical development processes
- Strong understanding of the clinical trial technology ecosystem (e.g., TMF, CTMS, LMS integrations)
- Excellent analytical skills, with the ability to interpret data and define meaningful TMF metrics and benchmarks
- Strong leadership, communication, and stakeholder management capabilities
Benefits
- Hybrid working model
- Professional development opportunities
- Chance to be part of a global organization committed to operational excellence and continuous improvement