Company: Docs Global (Continental Europe)
Reference: Ref AS-020418
Closing Date: 27 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
You have a strong motivation for nutrition, you are challenged by the offered variety of projects and opportunities. You are an experienced clinical project manager and a flexible team player.
Roles & Responsibilities of the position
The Clinical Study Manager is a member of the Clinical Studies Platform and provides scientific and/or operational clinical expertise in clinical research projects.
The CS Manager is responsible for the operational activities during the preparation and conduct of a clinical study. The position entails the full process of a clinical study, from study design, protocol writing, and preparations of the study, to management, analysis and reporting of the study.
The CS Managers are responsible for the day-to-day communication with the study team members at study level.
• Assess operational feasibility of the protocol
• Write Clinical Study Plan
• Develop Subject Information Sheet
• Arrange EC/regulatory submissions and approval
• Coordinate the selection of third parties (CRO’s, etc.)
• Supervise/monitor activities of third parties (e.g. CROs)
• Design CRF and study-specific documents
• Master’s or PhD degree, preferably in a life science or related scientific discipline;
• Several (3 - 5) 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;
• Clinical research methodology & statistics
• Scientific skills concerning both Danone products, clinical research, and literature data.
• Project management skills, including budget management, supplier management, planning and progress monitoring,
• Excellent communication skills (in English) to interact with a multidisciplinary project team within and outside Danone Research, including external partners such as investigators, CROs, ethics committees, and laboratories.
Our client has grown to be one of the biggest names in bringing health through nutrition by giving everyone the freedom to explore great ideas and pursue genuine innovations. It gives you an environment that's rich in autonomy and full of exciting possibilities.
2 Globeside, Globeside Business Park
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