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
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