Trial Master File Associate

• Maintain assigned study TMFs and ensure documents are filed accurately, contemporaneously, and according to TMF standards and company procedures

• Perform routine quality control reviews to identify missing, incomplete, duplicate, or misfiled documents and drive timely resolution

• Monitor TMF health, completeness, and timeliness metrics; communicate risks, trends, and outstanding issues

• Partner with Clinical Operations, CROs, vendors, and cross-functional teams on document flow and TMF filing expectations

• Support vendor and CRO reconciliation activities and TMF transfer processes

• Assist with audits and regulatory inspections by maintaining complete, accessible, inspection-ready documentation

• Track, reconcile, and help resolve TMF queries, issues, and corrective actions

• Support TMF plans, filing guidance, work instructions, SOPs, and related documentation

• Assist with user support, training, and adoption of eTMF processes and systems

• Contribute to TMF process improvements and quality initiatives

• Maintain compliance with company SOPs, ICH-GCP guidelines, and applicable regulatory requirements

• Bachelor's degree in Life Sciences, Health Sciences, or related fields or equivalent
• 2-4+ years of experience in TMF management, clinical document management, clinical operations, or clinical research within biotechnology, pharmaceutical, or CRO environments
• Working knowledge of the CDISC TMF Standard Model, ICH-GCP R(3) guidelines, 21 CFR Part 11, and applicable FDA and global regulatory requirements
• Experience maintaining electronic Trial Master Files (eTMF) in regulated clinical trial environments
• Hands-on experience with Veeva Vault eTMF and/or Trial Interactive platforms required
• Experience with TMF quality control, completeness reviews, reconciliation activities, and inspection readiness support
• Ability to analyze TMF health metrics and identify risks, trends, and gaps requiring follow-up
• Demonstrated commitment to quality, compliance, and continuous improvement
• Experience supporting FDA BIMO regulatory inspections preferred
• Experience supporting global clinical studies across multiple phases and working directly with CROs and external vendors preferred
• Familiarity with CTMS platforms and TMF-related inspection preparation activities preferred
• Experience supporting SOP development, TMF training, or process improvement initiatives preferred

Demonstrates expertise in Trial Master File (TMF) management, ensuring compliance with ICH-GCP guidelines and regulatory requirements while maintaining inspection-ready documentation. Proficient in electronic TMF systems and quality control processes to support clinical operations and continuous improvement initiatives.

• TMF Management
• ETMF Systems
• ICH-GCP Guidelines
• Veeva Vault eTMF
• TMF Quality Control

• TMF Management
• Clinical Document Management
• Quality Control Reviews
• TMF Health Metrics Analysis
• SOP Development
• Inspection Readiness Support
• Reconciliation Activities
• TMF Process Improvement
• CDISC TMF Standard Model
• 21 CFR Part 11 Compliance

• Commitment to Quality
• Attention to Detail
• Problem-Solving
• Collaboration
• Communication

• Clinical Operations
• Biotechnology
• Pharmaceutical
• CRO
• FDA BIMO Inspections

• Veeva Vault eTMF
• Trial Interactive
• CTMS Platforms