Trial Master Files Representative
Celerion(3 months ago)
About this role
The Trial Master Files Representative supports clinical research studies by preparing, organizing, and maintaining complete and compliant Trial Master Files for internal and external projects. The role ensures TMF structures and contents meet sponsor specifications and regulatory requirements. It involves frequent interaction with sponsors, project managers, monitors, and study sites to support protocol adherence and documentation standards. This position is fully remote and can be based anywhere in the US.
Required Skills
- Trial Master File Management
- Document Management
- Regulatory Compliance
- File Indexing
- Client Communication
- Stakeholder Coordination
- Interpersonal Communication
- Written Communication
- Organization Skills
- Collaboration Skills
+5 more
Qualifications
- Bachelor's Degree in Science
- Bachelor's Degree in Nursing
- Bachelor's Degree in Biomedical Discipline
About Celerion
celerion.comCelerion is an early‑phase clinical research organization that applies translational medicine to generate insights for early drug‑development decisions. They run first‑in‑human and healthy‑volunteer studies and provide clinical pharmacology, bioanalysis, biomarker and PK/PD services to support go/no‑go decisions. Combining scientific expertise with a large clinical capacity and operational experience, Celerion helps biotech and pharmaceutical sponsors accelerate development and bring products to market faster.
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