The Senior TMF Manager provides strategic leadership and hands-on oversight of the Trial Master File (TMF) across multiple clinical trials, focusing on eTMF system implementation, governance, and continuous improvement
Job Summary
The Senior TMF Manager provides strategic leadership and hands-on oversight of the Trial Master File (TMF) across multiple clinical trials, focusing on eTMF system implementation, governance, and continuous improvement.
Key responsibilities include leading eTMF system strategy and governance, ensuring quality and inspection readiness, defining and tracking metrics for continuous improvement, and fostering cross-functional collaboration.
This high-impact position offers the opportunity to shape TMF strategy and standards globally, lead system implementations, and drive operational excellence within a collaborative environment.
Matching Summary
The Senior TMF Manager provides strategic leadership and hands-on oversight of the Trial Master File (TMF) across multiple clinical trials, focusing on eTMF system implementation, governance, and continuous improvement.
Skills & Requirements
Must-have
eTMF system implementation and governance
TMF compliance with ICH-GCP
inspection readiness strategies
TMF KPIs and performance metrics
cross-functional collaboration with clinical teams
Nice-to-have
positive energy and teamwork
passion for dermatology
continuous improvement mindset
Key Requirements
8+ years clinical research experience
5+ years TMF management experience
Proven eTMF system implementation track record
Experience with leading eTMF platforms (e.g., Veeva Vault)
Demonstrated FDA and EMA inspection support
Bachelor's degree in Life Sciences or related field