Location: This position may be performed remotely but requires flexibility and willingness to travel as needed.
About the Role
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.
What You’ll Do
- 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.
What We’re Looking For
- 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
- 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 focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.
Company Overview
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.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to [email protected].
Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
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