Play a key role in ensuring excellence across our clinical documentation processes by managing the end-to-end Trial Master File (TMF)
Job Summary
Play a key role in ensuring excellence across our clinical documentation processes by managing the end-to-end Trial Master File (TMF).
Oversee CRO TMF activities, monitor performance, track KPIs, and ensure documentation is complete, accurate, and timely for both electronic and paper TMFs.
Support broader R&D Operations, including coordinating study-related contracts with vendors and exploring enhanced approaches to TMF management leveraging AI-enabled tools.
Matching Summary
Play a key role in ensuring excellence across our clinical documentation processes by managing the end-to-end Trial Master File (TMF).
Skills & Requirements
Must-have
TMF management
ICH-GCP guidelines
Veeva proficiency
CRO TMF oversight
Inspection readiness
Nice-to-have
AI-enabled tools
Continuous improvement
Risk-based approach
Cross-functional collaboration
Key Requirements
3-5 years of experience in TMF management
Bachelor's degree in Life Sciences or related field