TMF Quality Lead
Hybrid — Cambridge, UK (2 days on site)Full-timeClinical Operations
£55,000 – £68,000Applications close November 14, 2026
The TMF is where inspection findings are won or lost. You will own TMF quality for a group of client studies: setting the index, running completeness reviews, and keeping filing current rather than reconstructed in a panic three weeks before an inspection.
You will work directly with sponsor clinical operations teams and with the vendors who file into their eTMF, holding both to the same standard.
Responsibilities
- Run periodic TMF completeness and quality reviews against the DIA reference model
- Define study-specific TMF plans and index structures at study start-up
- Track filing timeliness and escalate persistent gaps to study leadership
- Prepare TMFs for inspection, including narrative explanations for known gaps
- Train sponsor and vendor staff on filing expectations
Requirements
- Four or more years working with Trial Master Files in a sponsor, CRO or consultancy setting
- Hands-on experience of at least one major eTMF platform (Veeva Vault, Montrium or similar)
- Detailed knowledge of the DIA TMF Reference Model
- Evidence of having taken a TMF through a regulatory inspection
- Comfortable telling a study team their filing is not good enough