2h ago
Director, Clinical Monitoring Oversight
Boston, Massachusetts
full-timedirectorbiotechnology
Description
You will provide strategic and operational leadership for global clinical site monitoring activities across Olema's clinical programs, ensuring compliance with GCP regulations and driving operational excellence, data integrity, and inspection readiness.
Requirements
- Bachelor's or Master's degree in a scientific discipline or related field
Responsibilities
- Provide strategic direction and operational oversight of all global monitoring activities
- Oversee internal clinical monitoring oversight team and FSP vendor
- Establish and maintain effective governance with FSP partner
- Define and implement monitoring strategy including risk-based and centralized monitoring
- Develop and monitor KPIs and quality metrics for site performance and FSP delivery
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