TMF Operations Lead

Praxis Precision Medicines, Inc.

15h • $99,000 - $119,000 • Remote

About The Position

The TMF Operations Lead plays a critical role in ensuring our clinical trial documentation is complete, accurate, timely, and always inspection ready. As our Trial Master File expert, you'll partner with Clinical Operations and cross-functional teams to build high-quality TMFs, identify and address risks early, and help ensure our studies are executed with confidence and compliance. You'll bring deep TMF expertise together with a practical, solutions-oriented mindset to continuously strengthen how we work. You'll provide meaningful insights into TMF health, champion best practices, and help teams stay focused on what matters most—delivering high-quality clinical trials that accelerate life-changing therapies for people living with complex central nervous system disorders.

Requirements

• Bachelor’s degree in life sciences, healthcare, or a related field, with at least 5 years of progressive experience in TMF operations or TMF management within the biotechnology, pharmaceutical, or clinical research industry.
• Deep working knowledge of ICH-GCP, FDA requirements, and other applicable global regulations and guidance governing clinical trial documentation and Trial Master Files.
• Strong experience with electronic TMF platforms; experience with Veeva Vault eTMF is strongly preferred.
• Expert understanding of TMF structure, content, lifecycle management, quality controls, and inspection-readiness expectations.
• Demonstrated ability to assess TMF health, interpret metrics, identify meaningful risks, and drive issues through resolution.
• Comfortable operating with autonomy, speaking up when risks emerge, and taking ownership for outcomes rather than waiting for direction.
• A collaborative, curious, and improvement-oriented mindset, with a willingness to challenge assumptions and build better ways of working.
• Regular use of a computer, devices, or other office equipment, clear communication, and occasional movement.
• Comfort with screen work, basic hand coordination, and sustained focus.

Nice To Haves

• Experience with Veeva Vault eTMF is strongly preferred.

Responsibilities

• Serve as the TMF subject matter expert and trusted partner to study teams, providing clear guidance on TMF requirements, expectations, and best practices throughout the clinical trial lifecycle.
• Lead the setup, maintenance, quality review, and closeout of electronic Trial Master Files, ensuring documentation is complete, accurate, contemporaneous, and inspection ready.
• Monitor TMF health, completeness, timeliness, and quality against study milestones; translate metrics and trends into clear insights, risks, and recommended actions for study teams and leadership.
• Partner with Clinical Operations, external vendors, and cross-functional stakeholders to maintain expected document lists, resolve gaps, and ensure documents are filed within established timelines.
• Identify, investigate, and drive resolution of TMF issues, including missing, late, or poor-quality documentation; escalate significant risks with appropriate urgency and clear ownership.
• Support inspection readiness activities, audits, and regulatory inspections by ensuring TMF documentation, processes, and supporting evidence meet applicable global requirements.
• Contribute to the development and continuous improvement of TMF procedures, work instructions, training, systems, and operating practices, incorporating evolving regulations and industry standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level