Key skills
LeadershipCommunicationDecision Making
About this role
Role Overview
- Lead cross-functional trial teams (Site Management, Monitoring, Data Management, Biostats, Safety, Clinical Logistics)
- Drive country and site feasibility across Europe and select sites based on clinical trial design requirements
- Author, review, and approve clinical study protocols and informed consent forms to ensure scientific integrity, regulatory compliance, and ethical standards
- Ensure protocol adherence, timely data entry, query resolution, and deviation management
- Coordinate with ethic committees and competent authority as needed
- Maintain inspection-ready documentation, drive continuous improvement and lessons learned
- Serve as the central point of contact for internal/external stakeholders
- Prepare updates, risk summaries, and decision briefs to senior leadership
- Develop timeline plans and proactively manage path to meet trial milestones (e.g. FPI)
- Provide robust vendor oversight (e.g. CROs), escalate and remediate as needed
- Lead and drive strategic initiatives, coordinating cross‑functional teams to ensure timely and high‑quality execution
Requirements
- Experience in leading a clinical trial in all phases (e.g. start up, execution and close out)
- Experience in medical devices and/or diabetes clinical trials
- Proficient at utilizing clinical management systems and electronic data capture systems
- Prior inspection/audit participation
- Familiar with post market clinical follow-up, registries, real-world evidence, or adaptive designs
- Detailed oriented, strategic thinking, problem solver, and drive decision making
- Excellent communication both verbal and written
Benefits
- A full and comprehensive benefits program
- Growth opportunities on a global scale
- Access to career development through in-house learning programs and/or qualified tuition reimbursement
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve