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R & D - Clinical Research Director - SH
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- Review the ICF WSI and TDF
- Assisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
- Medical support to clinical operations team on study plans: CMP/MRP, DR & DS review
- with operational support, bio stat and GSO
- Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
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