VacatureFreelance Clinical Study Manager [ingevuld door Carpe Diem]
Korte omschrijvingVoor een grote opdrachtgever ben ik op zoek naar een freelance Clinical Study Manager voor een opdracht van 4-6 maanden. Bij voorkeur voor minimaal 32 uur/week.
BedrijfsprofielA large, international company in the centre of the Netherlands.
Functie omschrijvingKey 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)
Functie eisenEducation
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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