Clinical Operations Manager
2 weeks ago
POSITION: Lead for Clinical Operations in the Medical Device sector
KEY RESPONSIBILITIES:
Oversee Clinical Trials Strategy and Implementation:
- Formulation of study protocols
- Management and presentation of data
- Creation of surgical procedures
Supervision of:
- Clinical trial sites
- External vendors
- Clinical and Regulatory advisors
Development of External Relationships:
- Partnerships with clinics
- Engagement with healthcare professionals in the therapeutic area
Departmental Advancement:
Enhance, develop, and oversee operational procedures
Leadership and Mentorship:
- Manage, train, and guide staff and consultants
Cross-Functional Collaboration:
- Work collaboratively with Research & Development, Operations, Quality Assurance, and Regulatory Affairs teams
Essential Qualifications:
- Extensive experience in US Investigational Device Exemption (IDE) trials, with a strong background in pivotal trials being advantageous
- Robust experience with medical devices, having worked on multiple devices rather than a single product
- Familiarity with device submission processes
- Availability to work onsite 2-3 days per week
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