Job Summary:

We are seeking a skilled and experienced Clinical Trial Master File (TMF) Manager to oversee the integrity, organization, and compliance of TMFs throughout the clinical trial lifecycle. This role involves managing TMF structures, ensuring document availability for audits/inspections, and providing guidance on TMF processes. The TMF Manager will be the Veeva Vault eTMF technical specialist and support vendors, CROs, and internal teams in maintaining the quality and compliance of trial documentation.

Responsibilities:

• Ensure TMFs fully reconstruct the conduct of clinical trials and are readily available for audits.
• Maintain secure TMF structures and create new ones as needed.
• Manage user access, archival repositories, and offsite storage locations.
• Define and execute TMF system migrations and quality control processes, ensuring compliance with regulatory requirements and industry standards (ICH, GCP, FDA).
• Collaborate with clinical teams and vendors to ensure TMF content management aligns with quality and compliance standards.
• Monitor CROs and external partners, ensuring adherence to document quality standards.
• Perform periodic reviews of TMF and vendor SOPs to ensure compliance with relevant regulations.
• Conduct quality control reviews of critical clinical documents (e.g., protocols, informed consent forms).
• Lead process improvements for TMF practices and system maintenance.
• Provide training and raise awareness of TMF quality and compliance standards.
• Serve as a resource during internal/external audits and regulatory inspections of TMFs.
• Support remediation of CAPA commitments and track findings through closure.

Qualifications:

• Bachelor’s degree required.
• 8+ years in the pharmaceutical, biotechnology, or medical device industry, with at least 3 years of TMF management experience.
• Strong knowledge of Good Clinical Practices (GCPs), ICH guidelines, FDA regulations, and eTMF systems (Veeva Vault required; “White belt” certification preferred).
• Demonstrated ability to manage global clinical trial programs and oversee TMF-related processes.
• Excellent analytical, organizational, and communication skills.
• Experience supervising teams or managing oversight of vendors.
• Familiarity with multiple eTMF systems and document management tools.