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Clinical Affairs Manager

Werkgever: SIRE Life Sciences B.V. Datum geplaatst: 18-01-2017 Regio: Noord-Brabant Datum gewijzigd: 18-01-2017
Functieomschrijving
The client is amongst the rising stars in the medical devices market with their breakthrough technology.

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.

Responsibilities

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.
Functie eisen
- Over 5 years of clinical trial experience in Class III medical devices
- 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
Bedrijfsomschrijving
SIRE Life Sciences® is a recruitment and executive search consultancy,
dedicated exclusively to the European Life Science industry.
SIRE Life Sciences® provides a Complete Life Science Cycle Search Solution to both Life Science Professionals
and Life Science Employers operating in the European Life Science Sector.
We provide a tailor made European wide service for both permanent and freelance solutions,
specialized in delivering to the world's leading Life Science institutions.
Sollicitatieprocedure
ARE YOU INTERESTED? 
Are you interested and are you the one we're looking for? Let us know and send your resume to CV(@)sire-search.com or give us a call on: +31 (0)20 658 9800