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Clinical Compliance Director
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$174,000 - $248,500 a year
Full-time
- Ensures clinical research activities are conducted by clinical staff in accordance with ICH GCP, relevant international and local regulations, requirements, and guidelines.
- The Director provides Good Clinical Practice (GCP) guidance and best-practice expertise to facilitate optimal clinical trial execution compliance management as it relates to Process Deviations and CAPA management to and ensure study adherence to applicable GCP regulations throughout all phases of clinical development.
- As part of Clinical Compliance and Risk Management (CCRM) Team, represent Development Operations and collaborate with Quality Assurance on compliance-related activities, processes and functions
- Establish and maintain CCRM key performance indicators, and metrics tools that interfaces with Quality Assurance representing the state of compliance for Development Operations
- Create and lead CCRM initiatives and infrastructure that drive compliance
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