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
* Manage the entire lifecycle of clinical trials
* Define and author clinical investigation documents by ISO 14155, ICH-GCP, and applicable standards
* Plan and control the budget, supervise the monitoring for assigned clinical studies
* Lead the study cross-functional team
* Responsable for Vendor selection and management
* Report relevant details and milestones to the management
* Maintain regular visits with study investigators and other study specific interfaces
Your Profile
* University degree or equivalent in scientific or medical field
* At least two years of experience in designing, planning, executing, analyzing and reporting global clinical trials
* Experience in clinical research would be an advantage
* Experienced in dealing with ethic and other competent authorities
* Fluency in English is a must, and German would be an advantage
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