Clinical Operations Supervisor at Duke Health coordinating patient care and managing personnel needs in Cardiology Diagnostic Unit. Implementing ambulatory health care services and departmental policies.
About the role
- Senior Clinical Project Manager role assisting in global clinical evidence planning and study design. Collaborating with various stakeholders to ensure data quality and compliance.
Responsibilities
- Works closely with key internal (Marketing, R&D, Market Access, Product Development) and external stakeholders (surgeon researchers) to develop global clinical evidence generation plans to support the various needs of the business (e.g., regulatory filings, supporting claims).
- Maintains relationships with Key Opinion Leaders in support of Clinical Affairs activities.
- Manage assigned Investigator Initiated Study proposals, reviews, and conduct.
- Supports the development of publication plans and their execution in combination with relevant internal and external resources.
- Supports and helps manage creation of publication summaries and dissemination of this information.
- Supports Clinical Research team, sometimes serving as the Clinical representative, interactions with regulatory authorities, notified bodies and during audits.
- Supports, sometimes serves as the point person, communicating project status updates, resource needs, and other information for assigned business units and product lines.
- Supports study design processes, including protocol development, while working closely with the Clinical Operations and Clinical Data Sciences teams.
Requirements
- Bachelor’s degree required; in a health sciences; preference for degrees in biological sciences, engineering, or related medical/scientific field preferred.
- 6+ years’ experience directly supporting clinical device research or similar experience in a medical device scientific area.
- Understanding of industry clinical research regulations and best practices (e.g., ISO 14155, ICH GCP).
- Preferred Excellent interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors, and external customers.
- High attention to detail and accuracy.
Benefits
- USD Annual salary plus bonus eligible + benefits
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