Clinical Trial Manager (CTM)
Corcept Therapeutics
Corcept Therapeutics seeks a Clinical Trial Manager to independently oversee medium to large clinical studies or multiple smaller trials. This hybrid role manages all clinical aspects, ensuring protocol compliance, GCP adherence, and successful study execution from startup through closeout.
Responsibilities
- Manage implementation and quality execution of assigned clinical protocols per SOPs and GCP standards
- Oversee study activities including startup, enrollment, maintenance, and closeout within timelines and budget
- Develop study documents including protocols, amendments, informed consent forms, and monitoring tools
- Provide training, guidance, and oversight to Clinical Research Associates with regular performance meetings
- Facilitate CRO/vendor selection, RFP development, proposal analysis, and contract negotiation
Requirements
- Clinical trial management experience with medium to large studies
- Knowledge of ICH/GCP guidelines and clinical SOPs
- Experience with protocol development and essential documents
- Vendor/CRO management and contract negotiation skills
- Project management and budget tracking abilities
- Cross-functional team leadership and communication skills
Vacancy posted 7 days ago
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