TMF Associate

Liquidia•,

About The Position

The TMF Associate supports the successful execution of clinical trials by ensuring the Trial Master File (TMF) is complete, inspection ready, and maintained in accordance with regulatory requirements, internal SOPs, and study timelines. This role collaborates closely with Clinical Operations, Quality, Regulatory, and CRO partners to drive high quality documentation practices across the study lifecycle. The TMF associate reports to the TMF specialist.

Requirements

Bachelor’s degree in life sciences, healthcare, or related field (or equivalent experience) if preferred.
1–3 years of experience in clinical research, preferably with direct TMF or document management responsibilities.
Familiarity with ICH GCP, TMF Reference Model, and regulatory documentation requirements.
Experience working with CROs or in a sponsor environment.
Understanding of clinical trial lifecycle and essential document requirements.
Strong organizational skills with the ability to manage multiple priorities and deadlines.
High attention to detail and commitment to documentation accuracy.
Proficiency with TMF systems (e.g., Veeva Vault, Wingspan, Trial Interactive, etc.) and Microsoft Office tools.
Excellent communication and collaboration skills.
Ability to work independently while contributing to a team-oriented environment.

Responsibilities

Maintain the electronic Trial Master File (eTMF) in compliance with ICH GCP, regulatory guidelines, and company SOPs.
Perform routine TMF health checks, quality reviews, reconciliation, and completeness reviews to ensure ongoing inspection readiness.
Upload, index, and QC essential documents with a high degree of accuracy and attention to detail.
Support TMF health assessments, metrics reporting, and remediation activities.
Track missing, overdue, or non-compliant documents and follow up with internal teams and CRO partners to ensure timely resolution.
Partner with Clinical Trial Managers, CRAs, and CRO counterparts to ensure consistent document flow and alignment with the TMF Reference Model.
Assist in TMF training for study team members and vendors, reinforcing documentation expectations and best practices.
Participate in study team meetings to provide TMF status updates and identify risks or gaps.
Prepare TMF documentation for internal audits, sponsor audits, and regulatory inspections.
Support audit findings resolution and corrective/preventive action (CAPA) implementation related to TMF processes.
Ensure all TMF activities are fully traceable and compliant with inspection standards.
Contribute to the development and refinement of TMF processes, templates, and SOPs.
Identify opportunities to streamline workflows and enhance documentation quality across studies.
Support system enhancements or migrations for eTMF platforms.