TMF Associate
Liquidia Technologies
United States
Posted on May 11, 2026
Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.
Job Summary
Knowledge, Skills, and Abilities
Job Summary
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.
Education and Experience
• 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.
• 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.
Knowledge, Skills, and Abilities
• 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.
• 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.
TMF Management & Quality
- 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.
Cross Function Collaboration
- 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.
Audit & Inspection Support
- 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.
Process Improvement
- 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.