TMF Specialist (eTMF) Job Description

Job Title: TMF Specialist (eTMF)

Work Location: Mountain View County, Massachusetts

Summary:

The TMF Specialist (eTMF) is responsible for the organization, maintenance, and quality control of the Trial Master File for clinical studies, ensuring compliance with regulatory standards and supporting audit readiness.

Responsibilities:

• Organize and maintain the Trial Master File in alignment with study plans and regulatory requirements, ensuring all documentation is accurate and up to date.
• Conduct regular quality control reviews of eTMF content to ensure completeness, accuracy, and timely filing, resolving any discrepancies or misfiled documents.
• Track and reconcile essential documents across multiple sites and vendors, proactively following up to close outstanding items before key milestones.
• Support audit and inspection readiness by keeping the TMF continuously prepared and assembling document packages as needed.
• Collaborate with clinical trial management and site start-up teams to ensure timely collection, indexing, and filing of essential documents.
• Generate and share TMF completeness and quality metrics with study leadership, escalating persistent gaps or risks as necessary.
• Maintain version control and assist with archival activities at study close-out, ensuring the TMF is complete and ready for inspection.
• Utilize eTMF platforms and tools to manage documentation workflows and support regulatory compliance throughout the study lifecycle.

Qualifications:

• 2+ years of experience managing TMF in clinical trials, preferably within a CRO or sponsor environment.
• Familiarity with ICH-GCP, DIA TMF Reference Model, and regulatory documentation requirements for the US and/or UK/EU.
• Hands-on experience with eTMF platforms such as Veeva Vault, Master Control, or similar systems, including document quality control.
• Strong attention to detail and organizational skills, with the ability to manage large volumes of documents and meet strict deadlines.
• Bachelor’s degree in a life science or related field, or equivalent relevant experience.
• Experience with CNS, psychiatry, or depression clinical trials is a plus.
• Background supporting multi-country studies, including knowledge of UK/EU essential-document requirements, is preferred.
• Prior involvement in inspection readiness activities or regulatory audits is advantageous.

Published Category: Clinical Operations & Development