We are seeking a Senior Clinical Operations Business Optimization Manager to drive process improvements and support key initiatives within Clinical Operations. The ideal candidate will bring strong clinical trial management experience and a passion for enhancing operational efficiency and compliance.
Key Responsibilities:
- 6+ years in pharma/biotech/CRO; 3+ years managing clinical trials
- Strong knowledge of GCP, regulatory requirements, and clinical systems
- Skilled in project management, communication, and stakeholder collaboration
- Identify and implement process improvement opportunities across Clinical Operations
- Support development of innovative practices, tools, and technologies
- Manage onboarding efforts and ensure SOP compliance
- Contribute to budget planning and operational metrics tracking
- Act as a resource for training, inspection readiness, and risk-based monitoring
- Collaborate with QA on CAPA closures and inspection follow-ups
- Stay current with industry trends, regulations, and best practices
- Up to 10% domestic/international travel
- Bachelor’s degree required; advanced degree or science/healthcare background preferred