The Clinical Supplies Manager is responsible for the management and logistics of clinical study supplies and study products. This includes communication and planning with the production facilities, ordering, managing randomisation processes and blinding, labelling, storage and distribution, retrieval and destruction, recall, and complaint handling for study products. The CS Supplies Manager is a member of multi-disciplinary study teams.
Key tasks
* Accountable for effectively managing clinical study supplies within set KPI's (timelines and budget) in accordance with clinical protocols, GCP, GMP and GDP other applicable international and/or local regulations as part of a multi-disciplinary clinical study team.
* Translate clinical protocol information into study product demand forecasts and supply strategy
* Coordinate production and release of clinical study products with the production facilities, product development, quality and food safety department and clinical study stakeholders.
* Arrange study specific product blinding and provision and supporting of randomisation and unblinding methods (incl. set-up of electronic systems).
* Prepare (country-specific) study product labels and arrange for (re)labelling of the study products in compliance with GCP and applicable regulations.
* Coordination of (study specific) clinical study supplies (e.g. equipment, printed materials and labkits), including ordering, distribution and instructions for use.
* Coordinate the selection of, and supervise third parties (e.g. warehouse, electronic system providers)
* Initiate and contribute to quality improvements, including participation in working groups and authoring SOP's.
Education & Knowledge
* Bachelor's or Master's degree in a life sciences or related scientific discipline
* Experience in (international) clinical study (product) management
* Familiar with ICH-GCP, GDP and GMP guidelines.
Skills
* Fluent in English (written and verbal)
* Pragmatic, systematic, efficient, quality focused working attitude
* Pro-active way of working
* Able to solve challenges with agile approaches
* Able to work in a fast-paced setting and handle and act under time-sensitive situations
* Excellent communication skills
* Team player and able to work independent
Benefits :
* Desired Start Date: 01/10/2025
* Duration: 12 months
* Hours per week: 32.00
* Open to employee and freelancers
* ±2 days/week on site in Utrecht
