TMF Document Specialist

Role Summary

The TMF Document Specialist is responsible for owning and overseeing the management and quality control of Trial Master File (TMF) documentation across multiple Phase I-IV global studies. This hands‑on role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to project teams. The TMF Document Specialist will play a key role in inspection readiness, process improvement, and training initiatives.

The TMF Document Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, Regulatory Affairs, and vendors/CROs to ensure the accuracy, completeness, and timeliness of TMF documentation.

• TMF Document Management & Oversight
  • Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements.
  • Lead and perform milestone TMF reviews, ensuring that all required documents are accurately filed, complete, and accessible.
  • Serve as a hands‑on TMF expert, guiding staff and study team members on best practices in document management.
  • Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks.
  • Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues; support implementation of corrective actions, as needed.
  • Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community including guiding key document attributes (i.e., classification of documents) and resolution of document queries.
  • Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible.
  • Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment.

• Project Team Support
  • Act as a senior liaison between vendors/CROs, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle.
  • Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with Study Specific TMF Plan and TMF Index.
  • Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues, in both an insourced and outsourced model.
  • Provide oversight of vendor/CRO TMF deliverables, including quality and adherence to contractual expectations.

• TMF Metrics & Reporting
  • Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data‑driven insights to identify areas for improvement.
  • Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes.
  • Provide regular TMF/eTMF status updates during Clinical Project Team Meetings and Clinical Operations Team meetings.

• Inspection Readiness
  • Ensure the TMF complies with all applicable regulatory requirements and guidelines.
  • Prepare for and support regulatory inspections and audits related to the TMF, including preparation of documentation.
  • Partner with Quality Assurance to build inspection readiness practices appropriate for a growing organization.

• Required:
  
  Bachelor’s Degree
• Required:
  
  3+ years of hands‑on Veeva Vault eTMF experience
• Required:
  
  5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience in a start‑up with global clinical trials is highly desirable.
• Preferred: TMF Certification or TMF training (e.g., DIA’s TMF Certificate Program, LMK TMF University) or other relevant certifications