Location: This position may be performed remotely but requires flexibility and willingness to travel as needed.
Position Summary
We are looking for a TMF Specialist to help organize, review, and maintain essential clinical trial documents in our electronic Trial Master File (eTMF) system. This role ensures our records meet quality standards and regulatory guidelines.
Key Responsibilities
- 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
- 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.
Compensation & Benefits
At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!
To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.
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.
Top Skills
Similar Jobs
What you need to know about the Charlotte Tech Scene
Key Facts About Charlotte Tech
- Number of Tech Workers: 90,859; 6.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Lowe’s, Bank of America, TIAA, Microsoft, Honeywell
- Key Industries: Fintech, artificial intelligence, cybersecurity, cloud computing, e-commerce
- Funding Landscape: $3.1 billion in venture capital funding in 2024 (CED)
- Notable Investors: Microsoft, Google, Falfurrias Management Partners, RevTech Labs Foundation
- Research Centers and Universities: University of North Carolina at Charlotte, Northeastern University, North Carolina Research Campus
