Senior manager clinical research (IMP-expert)

Senior manager clinical research (IMP-expert)
Senior manager clinical research (IMP-expert)

Published	Deadline	Location
today	19 Oct	Utrecht

Are you an Investigational Medicinal Project (IMP) specialist and keen to be part of a clinical research team within an academic, not-for-profit organization? We are looking for an IMP specialist with industry experience.

Job description
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.
Specifications

• 32—36 hours per week
• max. €6337 per month
• Utrecht View on Google Maps

University Medical Center Utrecht (UMC Utrecht)

Requirements

• You have at least 4 years experience in IMP management within a CRO or pharmaceutical company.
• You have sound knowledge and experience in relevant legislation and international GMP, GDP and GCP guidelines.
• You are a good communicator with an open mind to our academic working environment.
• 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 work efficiently and are goal oriented.
• You enjoy working in a team and always open to share your knowledge.

This is a temporary appointment for one year with the possibility of extension.
Conditions of employment
The maximum salary for this position (32 – 36 hours) is € 6.337,00 gross per month based on full-time employment.
In addition, we offer an annual benefit of 8.3%, holiday allowance, travel expenses and career opportunities. The terms of employment are in accordance with the Cao University Medical Centers (UMC).
Department
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.
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