Praxis Precision Medicines
TMF Operations Lead
RemoteUnited States only
- Role
- Operations
- Experience
- Senior
- Employment
- Full-time
$99k–$119k/yr
Check eligibility
Open to US only. Set where you work from to check your eligibility.
No BS summary
TMF Operations Lead with 5+ years of experience in TMF operations or management within the pharma/biotech industry. Requires deep knowledge of ICH-GCP, FDA regulations, and electronic TMF platforms (Veeva Vault preferred). Must be solutions-oriented and able to operate autonomously.
Core skills
Veeva Vault eTMFTMF operations
Required languages
English
What you'll do
- 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.
What they require
- 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.
Benefits
- Annualized Base Salary $99,000 — $119,000 USD
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.
$99k–$119k/yr