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The Opportunity:
- Play a critical role in ensuring clinical trial documentation is complete, accurate, and inspection ready.
- Partner with cross-functional teams to build high-quality TMFs and identify risks early.
Primary Responsibilities:
- Serve as the TMF subject matter expert, providing guidance on requirements and best practices.
- Lead the setup, maintenance, and closeout of electronic Trial Master Files.
- Monitor TMF health, translate metrics into insights, and drive resolution of issues.
Qualifications and Key Success Factors:
- Bachelor's degree in life sciences with at least 5 years of TMF experience.
- Deep knowledge of ICH-GCP, FDA, and global regulations for trial documentation.
- Experience with Veeva Vault eTMF strongly preferred.
About Praxis:
- A clinical-stage biopharmaceutical company focused on CNS disorders.
- Core values of Trust, Ownership, Curiosity, and Results.
- Committed to diversity, equity, and inclusion.
Praxis Precision Medicines
Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders. With a focus on trust, ownership, curiosity, and results, they foster a collaborative, inclusive culture.