In this role, you are part of the operational study team and responsible for the set up, documentation & maintainance all study related IMP procedures as required by ICH GCP and GMP and local laws and regulation in one of our ongoing platform trials for which the UMCU acts as sponsor. You are the team's expert on IMP labelling, shipment, handling & storage of IMPs, IMP quality control and overall drug accountability. You are able to perform risk assessments in every phase of the platform trial. You are the first point of contact for all IMP related matters internally and externally. You are the main contact person for the pharmaceutical companies delivering the IMP for the trial.
The European Projects Group (EUPG) (part of the department Epidemiology/Infections Diseases within the Julius Centre) is an operational clinical research group dedicated to perform high quality clinical research within the arena of infections diseases and antimicrobal resistance. The Julius Centre is one of the 12 divisions of the University Medical Centre Utrecht. The EUPG focusses on two main areas: 1) setting up & performing clinical trials and 2) the development & maintenance of a large international hospital and primary care network. The clinical trials are largely publicy funded. The EUPG is headed up by prof. dr. M.J.M. Bonten. The EUPG has around 55 employees and is expanding due to an increased portfolio.
This is a temporary appointment for one year with the possibility of extension.