Werkgever: SIRE Life Sciences B.V. Datum geplaatst: 18-01-2017 Regio: Noord-Brabant Datum gewijzigd: 18-01-2017
You are the guide and monitor of three clinical studies on several continents. You start out as the manager of a small pilot study and will be part of the US trial and help set up another trial in the EU. You will attend OR surgeries as well and report results to the senior clinical affairs manager.
There will be monthly travel involved to the facility in Switzerland and occasional further travel depending on the study sites.
You start out as the responsible person for the pilot study. You will gradually take over the study in the US depending on your current experience level. You will help set up the pivotal study in the EU and help identify and select study sites.
You review clinical data and manage documentation and reports. There will be collaboration with the company's R&D team, QA and clinical affairs team. You are responsible for reporting data and trial statuses to senior management.
- Familiar with EU and FDA regulations
- Proven experience in first man studies
- Experience/capability to join surgeon team to keep an eye on results; medical education is not required as the CMO takes care of that
- Fluent in English, German is a plus
- Availability to travel
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