Line management and daily guidance to Clinical Studies Managers to support them in their job
Act as primary contact for the internal sponsor of the clinical studies conducted
Manage timelines, resources, and quality of the clinical studies conducted
Ensure study set up and conduct is in accordance with Good Clinical Practice
Conduct and guide in the conduct of clinical trials, e.g.
- Arrange for regulatory and ethics submissions and approvals
- Develop and review study protocols
- Develop and review study documents, including CRFs
- 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 CROs and central labs
- Monitor clinical studies and/or coordinate (co-)monitoring activities, if CROs are involved
- Arrange site contracts
- Coordinate the process of data management and statistical analyses
- Write and review study reports and scientific publications
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A Master’s degree, preferably in a life science or related scientific discipline
Preferably several years of experience in (international) clinical research in the (bio-)pharmaceutical industry, including monitoring of clinical studies according to ICH-GCP guidelines
Familiar with medical terminology
Some knowledge of statistics will be useful
Fluent in English
Able to motivate, coach, and train team members and others in the conduct of clinical studies
Preferably experience in line management and/or coaching
Excellent communication skills and responsiveness to interact with a multidisciplinary project team and with all other parties involved, such as investigators and CROs
The ideal candidate has several years of relevant experience, is a team-player but also able to work independently, and is challenged by the variety of projects and opportunities offered.
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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
mobiel 06 50650550
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