TMF Operations Lead
Praxis Precision Medicines, Inc.
•Remote
About The Position
We’re looking for a dedicated and passionate TMF Operations Lead to ensure our clinical trial documentation is accurate, complete, and always inspection-ready. You’ll be the go-to TMF expert for our study teams and play a key role in driving quality, compliance, and innovation across trials.
Requirements
- 5+ years of TMF management experience and a bachelor’s degree.
- Deep knowledge of ICH/GCP, FDA, and international TMF requirements.
- Strong experience with eTMF systems (Veeva preferred).
- Expert understanding of TMF structure, content, and processes.
- Critical thinker who can solve problems quickly and effectively.
- Organized and detail oriented
- Great communicator and team player
Responsibilities
- Be the TMF subject matter expert and trusted partner to study teams.
- Oversee eTMF set-up, maintenance, and regular quality reviews.
- Monitor TMF health, milestones, and deliver metrics and insights to teams.
- Guide and support trial teams to stay compliant with document lists and timelines.
- Identify and resolve TMF issues, escalating when needed.
- Contribute to SOPs, processes, and industry best practices.
- Ensure access and compliance with global TMF standards and regulations.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
- Company match dollar-for-dollar up to 6% on eligible 401(k) contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Extremely flexible wellness benefit.
- Generous PTO.
- Paid holidays.
- Company-wide shutdowns.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
11-50 employees
