|Vacature||Clinical Study Supplies Manager|
|Korte omschrijving||Wij zijn per direct op zoek naar een Clinical Study Supplies Manager. Het betreft in eerste instantie een tijdelijke aanstelling voor 6 maanden.|
|Bedrijfsprofiel||Een groot, internationaal voedingsmiddelenbedrijf in het midden van Nederland.|
|Functie omschrijving||The 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).
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 eisen||Your 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