Leica Microsystems (Schweiz) AG

Your Responsibilities: Selects and manages experts and study sites. Drives, manages and executes research, pre-clinical (animal) and/or clinical studies, including post-market clinical follow-up. Authors study plans and protocols, with appropriate statistic rationales and methods of assessment, in accordance with intended clinical benefits and performance (study design). Ensures operational aspects of the studies are being conducted in accordance with all relevant ethical and government standards, Good Clinical Practices or Good Laboratory Practices, and company's procedures. Ensures submissions to regulatory competent authorities and ethics committees/IRBs, as required. On-site driving and executing studies, as required, per specific project. Analyses and discusses data and prepares study reports. Maintains a high level of professional expertise, staying abreast with scientific literature, product portfolio, and the competitive and healthcare environments. Supervises and reviews study data and documentation when collaborating with CROs. Drives process improvement initiatives which relate to the described responsibilities. Up to 50% travel.