Clinical Project Manager
BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.
The Medical Affairs Group with BIOTRONIK AG in Bülach, Zürich is responsable for the design, conduction and evaluation of international first-in-men, regulatory submission and post-marketing trials as well as investigator-initiated trials.
Your Responsibilities
1. Manage the entire lifecycle of clinical trials
2. Define and author clinical investigation documents by ISO 14155, ICH-GCP, and applicable standards
3. Plan and control the budget, supervise the monitoring for assigned clinical studies
4. Lead the study cross-functional team
5. Responsable for Vendor selection and management
6. Report relevant details and milestones to the management
7. Maintain regular visits with study investigators and other study specific interfaces
Your Profile
8. University degree or equivalent in scientific or medical field
9. At least two years of experience in designing, planning, executing, analyzing and reporting global clinical trials
10. Experience in clinical research would be an advantage
11. Experienced in dealing with ethic and other competent authorities
12. Fluency in English is a must, and German would be an advantage