[Hiring] TMF Operations Lead @Praxis Precision Medicines

Role Description

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.

Primary 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.

Qualifications

• 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.

Requirements

• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices, or other office equipment, clear communication, and occasional movement.
• You’ll need comfort with screen work, basic hand coordination, and sustained focus.
• Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Benefits

• Annualized Base Salary: $99,000 - $119,000 USD

Company Description

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.

• Our core Values of Trust, Ownership, Curiosity, and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.