Manager, Trial Master File

A company is looking for a Manager, Trial Master File (TMF). Key Responsibilities Provide end-to-end oversight of the Trial Master File (TMF) and ensure compliance with regulatory requirements Lead TMF quality review activities and manage TMF-related processes, standards, and documentation Act as the primary TMF point of contact for assigned studies and support TMF migrations and system upgrades Required Qualifications Bachelor's degree in Life Sciences, Health Sciences, or a related field required; advanced degree preferred 5+ years of clinical research experience with direct TMF or eTMF oversight In-depth knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements Strong experience with industry-standard eTMF systems Proven ability to manage multiple studies and train team members on system utilization

Created: 2026-03-05