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Senior Clinical Study Manager/ Senior CRA regio Utrecht
Deze vacature staat offline! | | De opdrachtgever
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Our customer is a global company in the centre of the Netherlands.
The Sr. Clinical Study Manager 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
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The Sr. Clinical Study Manager is responsible for:
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
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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
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Good salary, 5% gratification, 30 holidays, non-contributory pension, parttime work possible.
| | Contactinformatie
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Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Dr. Katja Ludwig
Consultant R&D
Biltstraat 443
3572 AW Utrecht
tel 030 231 7350
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