Job FunctionClinical Study Manager [ingevuld door Carpe Diem]
Short DescriptionThe Clinical Study Manager is responsible for the operational management of clinical studies including the preparation, initiation, conduct, progress reporting and closure of the studies in accordance with the Clinical Study Plan, ICH-GCP, applicable legislation and Standard Operating Procedures. The Clinical Study Manager can either lead the multi-disciplinary study team, or be a member of multi-disciplinary study team(s).
Company ProfileA large, international company in the centre of the Netherlands.
Function ProfileKey tasks
•Develop Clinical Study Plan
•Ensure progress reporting (resources, budget, timelines)
•Assess operational feasibility of study
•Select countries, sites, investigators
•Develop study documents, set-up and maintain study files
•Arrange EC/regulatory submissions, study registration
•Set up and manage study budget, contracts and payments (to sites, Third Parties)
•Coordinate the selection of, and supervise third parties (e.g. CRO's, suppliers, laboratory)
•Request for study product
•Perform/supervise site initiation and site management
•Perform/supervise site monitoring
•Safety reporting
•Safeguard quality of study and escalate compliance issues
•Align activities with team members (e.g. data management, supply management)
•Perform/supervise end-of-study activities (e.g. close out, archiving and study evaluation)

Reporting lines
The CS Manager reports to the (Senior) Clinical Studies Team Leader
Function CriteriaEducation
Master's degree in a life science or related scientific discipline
Knowledge
•Experience in (international) clinical study management, IHC-GCP guidelines
•Familiar with medical terminology
Skills (depending on the type of activities)
•Fluent in English (written and verbal)
•Project management skills, <including budget management, supplier management, project planning and monitoring of progress>
•Excellent communication skills <to interact with the internal multidisciplinary project team and external partners such as investigators/Key Opinion Leaders, CROs

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