TMF Operations Lead

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

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.

• 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.

• Patients First
• Scientific Rigor
• Integrity
• Urgency with Purpose
• Accountability

Physical and Mental Requirements include regular use of a computer, devices or other office equipment, clear communication, and occasional movement. Comfort with screen work, basic hand coordination, and focus is required. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Annualized base salary: $95,000 – $118,000 USD.

Benefits include 99% medical, dental, and vision premium coverage, company‑paid life insurance, AD&D, disability benefits, voluntary plans, a 401(k) match up to 6% with long‑term stock incentives, a discretionary quarterly bonus, flexible wellness benefits, generous PTO, paid holidays, and company‑wide shutdowns.