Dit ga je doen
As Senior Project Manager (Sr PM) you are responsible for the set up & conduct of complex clinical trials within the applicable law & regulations, ICH/GCP guidelines and UMCU/ EUPG SOPs. For most trials, the UMCU acts as sponsor and you are fully aware of the ICH GCP sponsor requirements you must adhere to. You trive to work in a fast changing enviroment and you find it rewarding to work in an internation academic setting. The EUPG are proud to conduct clinical research that is embedded in medical practice and focussing on true patient needs. Having broad experience in all phases of the clinical trial life cycle is a must. It is of great advantage if you have audit and/or health authority inspection experience. You are quick in understanding various research designs and you have solid experience in the regulatory set up of a trial, IMP handling, safety monitoring & reporting, data monitoring . You are comfortable in working with study budgets and know how to manage key stakeholders. Last but not least, you have clear capacities in heading up a study team. You report to the EUPG programmanager.
Hier ga je werken
The Julius Centre is one of the 12 divisions of the University Medical Centre Utrecht. The European Projects Group (EUPG) (part of the department Epidemiology/Infections Diseases) is an operational clinical research group dedicated to perform high quality clinical research within the arena of infections diseases and antimicrobal resistance. The EUPG focusses on two main areas:
- setting up & performing clinical trials and;
- 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.
Dit neem je mee
You have at least 6 years experience in international project management within a CRO or pharma company. You are an enthousiastic and driven clinical project manager and understand how to direct a project team. You are keen to work in a not-for-profit working environment and happy to participate in a larger group of clinical research professionals. You have a solid knowledge on ICH GCP and applicable law & regulations. As a SR PM you keep (sponsor) oversight at all times. You work smart and effective, are a good communicator, decisive and you know ''how to get the job done''.
This is a temporary appointment for one year with the possibility of extension.
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