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Clinical Study Organizer Lead
hace 2 meses
Job Summary
As a key member of the Edwards Lifesciences team, the Clinical Study Organizer Lead will be responsible for overseeing and supervising clinical study activities. This involves providing oversight of and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality. The successful candidate will work closely with principal investigators, support staff, and study sponsor management and leadership staff to ensure the smooth execution of clinical trials.
Key Responsibilities
- Organize and supervise clinical study activities, including protocol compliance, enrollment, monitoring deviations, and data quality
- Provide oversight and insights into trial activities to principal investigators, support staff, and study sponsor management and leadership staff
- Assist with resolving problems, including background and actions to prevent reoccurrences
- Conduct Clinical Monitoring activities as required
- Serve as key contact to assigned clinical sites throughout the study process
- Ensure achievement and reporting of agreed clinical milestones
Requirements
Bachelor's Degree in a related field, 5 years experience of previous related medical device and/or clinical experience required or Associate's Degree or equivalent in a related field, 7 years experience of previous field monitoring experience, quality assurance/control and regulatory compliance required.
