[Hiring] TMF Operations Lead @Praxis Precision Medicines

Role Description

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.

• 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.

Qualifications

• 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.

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.
• Comfort with screen work, basic hand coordination, and focus.
• Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Benefits

• 99% of the premium paid for medical, dental and vision plans.
• Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
• Dollar-for-dollar match 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, and company-wide shutdowns.
• Join a phenomenal crew of colleagues who are smart, engaged, and inspiring.

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.

• Core Values: Trust, Ownership, Curiosity, and Results.
• Commitment to diversity, equity, and inclusion.