Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The OpportunityThe 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 and Key Success Factors- 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.
- 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.
Annualized Base Salary
$99,000-$119,000 USD
