Responsibilities:
- Set up, maintain, reconcile, and archive electronic and paper Trial Master Files
- Coordinate TMF transfer with CROs
- Assist with auditing and reconciling all study-related documents for clinical studies
Requirements:
- Bachelor’s degree
- 5+ years of relevant hands-on study experience in clinical research, ideally within a sponsor setting
- Exceptional communication (oral and written), organizational, and problem-solving skills
Additional Skills:
- High-energy individual able to effectively multi-task and strive in a dynamic start-up environment
- Strong attention to detail
- Solid knowledge of GCP guidelines and other regulatory requirements for clinical trial management
Vedanta Biosciences
Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks.