Trial Master File (TMF) Associate

Job Summary

We are seeking a highly organized and detail-oriented Trial Master File (TMF) Associate to support the management, quality, and inspection readiness of clinical trial documentation throughout the clinical study lifecycle. The TMF Associate serves as a key partner to Clinical Operations, CROs, vendors, and study teams, ensuring TMF records are complete, accurate, contemporaneous, and maintained in accordance with ICH-GCP guidelines, regulatory requirements, and company procedures. This role contributes to TMF oversight activities, quality reviews, reconciliation efforts, health metric reporting, and continuous process improvement initiatives to support an inspection-ready TMF environment.

Responsibilities:

• 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 with study teams and functional areas.
• Monitor TMF health, completeness, and timeliness metrics; proactively communicate risks, trends, and outstanding issues to stakeholders.
• Partner with Clinical Operations, CROs, vendors, and cross-functional teams to ensure consistent document flow and adherence to TMF filing expectations.
• Support vendor and CRO reconciliation activities and assist with management of TMF transfer processes to ensure documentation completeness across all sources.
• Assist in preparing for audits and regulatory inspections by ensuring TMF documentation is complete, accessible, and inspection-ready.
• Track, reconcile, and help resolve TMF queries, issues, and corrective actions in collaboration with study teams and vendors.
• Support TMF plans, filing guidance, work instructions, SOPs, and other TMF-related documentation as needed.
• Assist with user support, training, and adoption of eTMF processes and systems.
• Contribute to TMF process improvements and quality initiatives that enhance compliance, efficiency, and inspection readiness.
• Maintain compliance with company SOPs, ICH-GCP guidelines, and applicable regulatory requirements.

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.

Preferred Requirements:

• Experience supporting FDA BIMO regulatory inspections.
• Experience supporting global clinical studies across multiple phases and working directly with CROs and external vendors.
• Familiarity with CTMS platforms and TMF-related inspection preparation activities.
• Experience supporting SOP development, TMF training, or process improvement initiatives.

What We Offer:

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.