Manager Trial Master File

TMF Manager

Location: Lexington, MA (Hybrid – On-site Monday–Thursday, Remote Friday)

Our Client:

Our client, a growing biopharmaceutical company, is seeking an experienced and proactive Trial Master File (TMF) Manager to lead their TMF operations. This individual will oversee the setup, maintenance, and inspection readiness of TMFs for clinical studies in compliance with ICH-GCP guidelines and regulatory standards.

This is a hybrid role based in Lexington, MA, with on-site requirements Monday–Thursday and remote work on Fridays.

Key Responsibilities:

• Oversee TMF operations for multiple clinical studies, serving as the subject matter expert (SME).
• Collaborate with clinical study teams and CROs to ensure TMF compliance and quality throughout the study lifecycle.
• Conduct oversight reviews, gap analyses, and inspection readiness activities.
• Develop and maintain TMF plans, SOPs, and user access protocols.
• Run operational metrics, address TMF discrepancies, and ensure audit preparedness.
• Lead TMF process improvements and support system updates, including user acceptance testing.

Required Qualifications:

• Bachelor’s degree
• Minimum 5 years of experience managing TMFs in pharmaceutical/biotech company
• TMF setup experience
• Expertise with electronic TMF systems; experience with Veeva Vault is required.
• Strong knowledge of ICH-GCP guidelines, clinical trial processes, and regulatory standards.
• Proven track record in inspection readiness and preparation.