Trial Master File (TMF) Associate

POSITION SUMMARY

The TMF Associate will support day-to-day Trial Master File (TMF) Operations activities, including TMF projects, key performance indicators (KPIs), the electronic Trial Master File (eTMF) system, and vendor TMF activities. The TMF Associate will serve as a functional subject matter expert (SME) and ensure strong adherence to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Good Documentation Practices, International Council for Harmonization (ICH) E6(R2), and ALCOA+ standards.

The candidate will interact with external vendors and internal cross-functional teams, playing a critical role in TMF management, sponsor oversight, inspection readiness, and compliance with applicable global regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Partner with Clinical Operations to define the TMF Plan and TMF Index for each study and initiate updates as applicable.
• Ensure functional compliance with company and/or CRO/vendor TMF SOPs, KPIs, relevant TMF processes, supporting guidance, and applicable global regulations.
• Conduct document-level quality checks and work with document owners to resolve quality issues, as defined in TMF-related SOPs.
• Define expected study documents and maintain appropriate placeholders or Expected Document Lists within the eTMF system in collaboration with Clinical Operations and CRO partners.
• Perform risk-based quality control reviews and TMF health assessments as part of sponsor oversight and to ensure compliance with TMF-related SOPs.
• Generate, organize, and deliver internal TMF performance metrics at Core, Country, and Site levels, with a focus on identifying trends in completeness, quality, and timeliness and escalating concerns as appropriate.
• Monitor external TMF performance metrics for TMF activities outsourced to CROs and other vendors and escalate concerns as needed.
• Ensure documents that do not meet TMF quality, content, or inspection-readiness requirements are effectively remediated by internal and external stakeholders; provide best-practice recommendations as needed.
• Coordinate long-term archival and storage of original documents and maintain document integrity in accordance with applicable retention requirements.
• Collaborate effectively with cross-functional teams and external partners to support consistent TMF processes and inspection readiness.
• Demonstrate a commitment to organizational values, including teamwork, integrity, innovation, accountability, and patient focus.

REQUIREMENTS

Education

• Bachelor’s degree in a technical, scientific, or related discipline required.

Experience & Qualifications

• 3+ years of clinical research experience, including relevant experience in document management, vendor oversight, quality control review, and comprehensive TMF completeness reviews.
• Knowledge of or experience with AI-enabled TMF solutions highly preferred.
• Strong understanding of the drug development process, ICH guidelines/GCP, clinical trial processes, SOP application, and relevant medical terminology.
• Self-motivated with the ability to collaborate effectively and influence others in a cross-functional environment.
• Strong interpersonal, problem-solving, organizational, and planning skills.
• Excellent verbal and written communication skills.
• Strong attention to detail with the ability to prioritize and manage multiple tasks against critical deadlines.
• Proficiency with Microsoft Office Suite, including Word and Excel.