Clinical Operations Manager overseeing a team and ensuring adherence to SOPs in pharmaceutical projects. Leading training and performance management while collaborating with senior management.
About the role
- Senior Clinical Operations Manager managing clinical studies and regulatory compliance at Philips. Collaborating across teams for operational optimization and continuous improvement.
Responsibilities
- leads and oversees all aspects of clinical study management
- ensures strict compliance with regulatory requirements (ISO, GCP, FDA) and Philips procedures
- serves as a subject matter expert for study sites and investigators
- reviews and verifies study documentation and data
- develops study plans and protocols
- manages cross-functional relationships and facilitates communication
- monitors study progress and conducts data analysis
- delivers timely updates and recommendations to senior management
Requirements
- 10+ years of experience in clinical research
- Knowledge and experience with peripheral vascular strongly preferred
- cardiac or coronary experience and knowledge required
- strong knowledge of all relevant regulations, standards, and guidelines (ISO, GCP, etc.)
- Familiarity with Cath Lab Operations is required
- bachelor's degree or higher in a related field
- nursing backgrounds with extensive clinical research experience in the cardiac space will also be considered
- willing and able to travel up to 25% as required by business needs
Benefits
- generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement
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