VacatureClinical Study Supplies Manager
Korte omschrijvingWij zijn per direct op zoek naar een Clinical Study Supplies Manager. Het betreft in eerste instantie een tijdelijke aanstelling voor 6 maanden.
BedrijfsprofielEen groot, internationaal voedingsmiddelenbedrijf in het midden van Nederland.
Functie omschrijvingThe CS Supplies Manager is responsible for the high quality management of clinical study supplies and study product and the logistics. This includes communication and planning with the production facilities, ordering, randomization, labeling, storage and distribution, retrieval and destruction, recall of, and complaint handling for study products.
You are member of multi-disciplinary study team(s).

Your responsibilities
•Coordinate clinical study product production and storage
•Arrange study product blinding, provision of code envelopes and unblinding instructions
•Prepare (country-specific) labels, arrange for (re-)labeling of the study products
•Manage the approval (release) process for study products
•Distribution of clinical study products and request for required documentation, i.e. import license
•Manage complaints and recall, if applicable
•Coordination of printing Case Report Form and other study-related documents
•Ordering of clinical study supplies (e.g. equipment)
•Maintain information on relevant legal requirements
•Coordinate the selection of, and supervise third parties (e.g. warehouse)
Functie eisenYour Profile
You have a bachelor or master's degree in a life science - or related scientific area. You have at least 2-5 yrs relevant experience in (international) clinical study management and experience in logistics and supplies handling, preferably within clinical research in the (bio-pharmaceutical) industry.
In addition, the candidate is:
•Familiar with ICH-GCP guidelines, Good Distribution Practices, Good Manufacturing Practices Annex 9.
•Fluent in English (written and verbal)
•Practical, systematic, and has an efficient working attitude
•Able to set priorities in case of urgent requests or complex situations
•Excellent communication skills to interact with the internal multidisciplinary project team, with external partners such as production locations, suppliers and couriers, and other (logistic) service providers

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