[Hiring] TMF Specialist @Liquidia

Role Description

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.

Qualifications

• 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.

Requirements

• 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.

Benefits

• 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.