VacatureClinical Project Manager [ingevuld door Carpe Diem]
Korte omschrijvingVoor een klant in regio Utrecht zoek ik een ervaren Clinical Project Manager. Ervaring in oncologie en/of alzheimer is een pre.
BedrijfsprofielA growing company with a large diversity in local and international trials.
Functie omschrijving•Starts-up/manages (complex) clinical trials in accordance with all relevant guidelines, legislation and SOPs
•Writes or assists in the writing of a Project Management Plan
•Develops study-specific documentation (in cooperation with Quality, Training and Compliance department)
•Monitors the progress of the clinical trial against the project plan and previously defined performance indicators in terms of quality, quantity and budget, and adjusts implementation as necessary
•Reports progress made to the sponsor, the next level internally and the study’s Steering Committee (if applicable)
•Plans, organises and participates in meetings for investigators, CRAs, etc.
•Coordinates the activities of the project team and identifies capacity problems with respect to the individual and team workload
•May act as a point of contact for the sponsor and all members of the project team
•Provides prompt and clear information to all members of the project team and the sponsor with regard to study activities, upon which appropriate and quick decisions can be made with regard to the organisation and implementation of the trial
•Manages the study costs in accordance with the sponsor contract and the budget
•Works together with the legal advisors when site/investigator contracts, vendor and partner contracts have to be negotiated and executed
•Contributes to process improvements, e.g. professionalisation of work activities, methods of reporting, implementation of new legislation and regulations
Functie eisen•Higher level of education, preferably in a biomedical field
•Up-to-date knowledge of legislation and regulations and ICH/GCP guidelines
•A minimum of 5 years’ experience in the pharmaceutical and/or CRO industry
•Preferably a minimum of 2 years’ experience as a (junior) Project Manager
•Experience in the therapeutic area Oncology and/or Alzheimer’s is an advantage
•Certification in project management is preferable

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