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Clinical Affairs Manager (h/f)

Ref 1258570

Geactualiseerd op 29 augustus 2020 via STEGMANN BELGIUM

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We are looking for a Clinical affairs Manager for one of our clients in Antwerp. 

Management and coordination of conduct of PMCF/clinical trials with a focus on medical devices including the planning, start-up, progress and closure; and to maintain quality and integrity of study data in accordance with protocol, company SOPs, applicable laws (MDR/MDD), standards (ICH-GCP, ISO 14155) and guidelines; Review, preparation, coordination and follow-up of CT submissions to ethics committees and competent authorities Assurance that clinical trial projects are properly resourced, managed and executed according to established objectives, budget and timelines; Manage the day-to-day clinical operations, including management of vendors (e.g. CRO) and coordination of activities; Pro-active identification of project specific issues and set up strategies to handle this efficiently; Support/lead of feasibility assessments and selection of countries and sites for clinical studies; Proactive collaboration with investigators/study team; Provision of feedback to the clinical line manager regarding study progress
  • Etudes, recherche et développement / Recherche fondamentale et appliquée

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Naam van de werkgever
Mr Belgium Stepstone

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Opgelet! Het is niet nodig om Actiris te contacteren voor deze werkaanbieding. De vacature werd opgesteld door de werkgever. Actiris is niet verantwoordelijk voor de inhoud ervan en eventuele inbreuken tegen de wetgeving. Toch een opmerking over deze werkaanbieding? Aarzel dan niet om Actiris in te lichten.