About the Company
Our client, a clinical-stage biotechnology company developing unique oncologic drugs treatments, is currently seeking a Clinical Trial Manager to join their rapidly growing team. The Clinical Trial Manager will manage various aspects of clinical trials from study start-up through database lock in coordination with clinical operations leadership and later commercialization.
- Managing operational aspects of clinical trials from study start-up through database lock as assigned, with adherence to stated goals, timelines, budgets, and applicable regulatory requirements.
- Managing study-related vendors including CROs and contract labs.
- Reviewing monitoring reports, protocol deviations and data listings to ensure reliable quality data is and has been delivered
- Performing site visits (qualifications, initiations, routine monitoring visits, closeouts) and ensuring visit-related documents are generated
Share This Position:
- Bachelor’s degree or equivalent in the life sciences or related field
- 7 + years of experience with site monitoring and study/ CRO vendor management with previous experience with oncology, combination drug-device studies, and/or global clinical trial experience
- Strong working knowledge of drug development process, GCP, ICH guidelines and FDA regulations.
- ACRP CCRA certification a plus