- 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
- 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) is 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.
- 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. 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.
Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, and more!
Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
Recruiting Agencies, Please Note
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.
