TMF Specialist

Liquidia•,

About The Position

The TMF Specialist serves as a subject matter expert (SME) for Trial Master File management across clinical programs. This role ensures the TMF is complete, accurate, and inspection ready at all times, while driving quality standards, process improvements, and where vendor oversight applicable. The TMF Specialist partners closely with Clinical Operations, Quality, Regulatory, and CRO teams to ensure documentation excellence throughout the study lifecycle. The TMF Specialist reports to a Director in Clinical Operations or a TMF Lead.

Requirements

Bachelor’s degree in life sciences, healthcare, or related field (or equivalent experience).
Typically 3–5+ years of experience in clinical research with direct TMF ownership or oversight.
Strong working knowledge of ICH GCP, TMF Reference Model, and regulatory documentation requirements.
Experience collaborating with or overseeing CROs.
Deep understanding of TMF structure, essential documents, and clinical trial lifecycle.
Strong analytical skills with the ability to identify trends, risks, and quality gaps.
High attention to detail and commitment to documentation accuracy.
Proficiency with eTMF systems (e.g., Veeva Vault, Wingspan, Trial Interactive).
Excellent communication, stakeholder management, and problem solving skills.
Ability to work independently and lead TMF-related initiatives.

Nice To Haves

Experience supporting regulatory inspections (FDA, EMA, MHRA).
Familiarity with risk-based TMF management approaches.
Experience with multiple therapeutic areas or global studies.
Prior involvement in SOP development or process optimization.

Responsibilities

Act as the TMF SME for assigned studies and assets, ensuring alignment with ICH GCP, regulatory expectations, and the TMF Reference Model.
Lead routine TMF quality reviews, completeness checks, and reconciliation activities with internal teams and CRO partners.
Monitor TMF health metrics, identify trends or risks, and drive timely remediation.
Ensure consistent document indexing, metadata accuracy, and adherence to filing conventions.
Oversee TMF milestones (e.g., study start up, interim reviews, close out) and ensure documentation is inspection ready at each stage.
Provide oversight of CRO TMF activities, including document flow, quality, and timeliness.
Review CRO TMF metrics and KPIs; escalate gaps and collaborate on corrective actions.
Participate in vendor governance meetings to ensure TMF expectations are met.
Serve as a key contributor during internal audits, sponsor audits, and regulatory inspections.
Prepare TMF documentation, narratives, and evidence packages to support inspection activities.
Lead or support CAPA development and implementation related to TMF findings.
Partner with CTMS, CRAs, regulatory, and quality teams to ensure high quality documentation practices.
Provide TMF training, guidance, and coaching to study teams and vendors.
Support onboarding of new team members to TMF processes and systems.
Contribute to the development, revision, and rollout of TMF SOPs, work instructions, and templates.
Identify opportunities to streamline workflows and enhance documentation quality.
Support eTMF system enhancements, UAT testing, and configuration updates.
Champion best practices and continuous improvement initiatives across Clinical Operations.