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Clinical Trial Manager
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Full-time
- Primary operational contact for execution of the study in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions
- Operational input into study documents such as synopsis, protocol, Informed Consent Forms, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, etc.
- Lead both an internal and external/CRO trial management team, to ensure the successful conduct of the trial in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
- Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF)
- Bachelor's degree, or equivalent, in a biomedical, life science or related field of study
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