Senior Clinical Study Manager (interim)Deze vacature staat offline! |
| De opdrachtgever |
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De opdrachtgever Our customer is a pharmaceutical company in the centre of the Netherlands. The Sr. Clinical Study anager is a member of the Clinical Study department and will provide expertise in clinical research projects. The position entails the set up and coordination of international, multicenter trials in various therapeutic areas. The function will include the development of study protocols and other trial documents, arranging the regulatory and ethics approvals, and performing selection and monitoring visits, and selection and management of contract research organisations. Involvement and (scientific) development is possible into the areas of data management, statistical analyses and in the scientific reporting of the results. De omschrijving |
| The Sr. Clinical Study Manager is responsible for |
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Ensure study set up and conduct in accordance with Good Clinical Practice. Arrange for regulatory and ethics, submissions and approvals. Develop study protocols, develop study documents, including CRF’s. Provide input into the protocol development process and study analyses phases. Select investigators and take part in the selection process of third parties, such as CRO’s and central labs. Monitor clinical studies and/or coordinate (co-)monitoring activities, if CRO’s are involved. Arrange site contracts and manage budget and timelines Coordinate the process of data management and statistical analyses. De eisen Master’s or PhD degree, preferably in a life science or related scientific discipline. At least 3 years of experience in (international) clinical research in the (bio-) pharmaceutical industry. Experience in monitoring of clinical studies according to ICH-GCP guidelines. Excellent communication skills and responsiveness to interact with a multidisciplinary project team and with all other parties involved, such as investigators and CRO's Able to train site staff and coach others in conduct of clinical trials. Familiar with medical terminology, and some knowledge of statistics will be useful. Fluency in English. Independent, teamplayer, communicative, analytical and output focused. De arbeidsvoorwaarden Good salary, 5% gratification, 30 holidays, non-contributory pension, parttime work possible. Contactinformatie |
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Dr. Katja Ludwig Consultant R&D Biltstraat 443 3572 AW Utrecht tel 030 231 7350 |
