Job Title: Senior Manager, Trial Master File (TMF)

Work Location: Remote-EST/CST

Summary:

The Senior Manager, Trial Master File (TMF) will provide strategic leadership and operational oversight for TMF management, ensuring inspection readiness and compliance with regulatory requirements. This role will serve as TMF Lead for multiple clinical studies, collaborating cross-functionally and overseeing eTMF systems, with a focus on Veeva Vault Clinical.

Responsibilities:

• Lead TMF strategy, governance, and oversight for assigned clinical studies, ensuring compliance with ICH/GCP guidelines and regulatory requirements.
• Drive inspection readiness activities for internal audits and health authority inspections, maintaining a state of continuous audit preparedness.
• Oversee eTMF system governance, including Veeva Vault Clinical, Wingspan eTMF, and ClinTrak eTMF, ensuring accurate and timely documentation management.
• Author and maintain TMF-related SOPs and work instructions, ensuring alignment with industry standards and best practices.
• Collaborate cross-functionally with Clinical Operations, Data Management, Regulatory, Quality, and external partners to support TMF lifecycle management.
• Mentor and provide guidance to TMF staff, fostering a culture of quality and continuous improvement.
• Ensure robust TMF governance and process building, supporting rare disease and neurology clinical programs.
• Provide oversight of CRO partners, ensuring sponsor-side TMF requirements and standards are met.

Qualifications:

• Bachelor’s degree required.
• 8 to 10 years of TMF management experience in a sponsor-side environment.
• Minimum 5 years of hands-on experience with Veeva Vault Clinical (required).
• Expert knowledge of ALCOA+, GCP, GDP, ICH E6(R2/R3), and the TMF Reference Model.
• Demonstrated experience in inspection readiness and regulatory compliance for TMF.
• Experience authoring SOPs and work instructions for TMF processes.
• Strong cross-functional collaboration and process-building skills.
• Experience overseeing CROs and managing TMF for rare disease or neurology studies preferred.

Published Category: Clinical Operations & Development