Associate Director, Trial Master File (TMF)

Position Summary

The Associate Director, Trial Master File (TMF) will report to a senior leader within Clinical Development Operations and is responsible for the strategic oversight, governance, and continuous improvement of the electronic Trial Master File (eTMF) across the clinical development portfolio.

This individual will ensure TMF processes, systems, and controls support inspection readiness, regulatory compliance, and efficient clinical trial execution. The role provides leadership over TMF strategy, vendor oversight, inspection preparedness, and cross-functional alignment, ensuring TMF completeness, quality, and timeliness throughout the study lifecycle.

The Associate Director serves as a key partner to Clinical Operations, Quality, Regulatory Affairs, and external vendors, maintaining sponsor accountability for TMF integrity while enabling scalable operations within a growing clinical-stage biotechnolo...