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Role Description

We’re looking for a TMF Specialist who takes pride in precision and understands that great clinical science depends on disciplined execution. You will own the organization, quality review, and integrity of essential trial documents within our electronic Trial Master File (eTMF) system. Your work ensures our studies stand up to regulatory scrutiny — and ultimately helps us deliver therapies to patients faster.

• Review and quality check trial documents to ensure accuracy and compliance.
• File and maintain essential records in the eTMF system.
• Flag and track quality issues, ensuring they are resolved quickly.
• Support filing and archiving across multiple clinical studies.
• Work closely with TMF Operations Lead to update filing processes and guidelines.
• Help manage periods of high document submission.

Qualifications

• Bachelor’s degree or equivalent
• 2-4 years of experience in clinical trials, TMF, or related roles (Sponsor, CRO, or Site)
• Knowledge of ICH-GCP, good documentation practices, and eTMF systems (e.g., Veeva)
• 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. 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.

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.
• A collaborative and inspiring work environment.
• Annualized base salary compensation in the range of $75,000 — $93,000 USD.

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. 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.

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.