Trial Master File Manager

Job Summary

A company is looking for a Trial Master File (TMF) Manager.

Key Responsibilities:

• Act as a central contact for Clinical Study Teams for TMF management and develop quality oversight processes
• Oversee TMF and CTMS activities, ensuring adherence to regulatory guidelines and SOPs
• Collaborate with vendors and internal teams to manage TMF documentation and maintain inspection readiness

Required Qualifications:

• RN or bachelor's or master's degree desired
• Minimum of 8+ years in a pharmaceutical or regulated environment
• Strong experience with FDA Regulations, ICH Guidelines, and GCP
• Proficient in electronic document management systems, including eTMF and CTMS
• Experience in managing CROs/vendors and overseeing study TMFs