The CS Supplies Manager reports to the CS Supplies Coordinator.
• 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.
• 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.
• 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.
• Understanding of clinical study procedures
• Understanding of project management and supply chain management in clinical studies
• 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 <to interact with the internal multidisciplinary project teams, higher management, external partners, suppliers and couriers, and other (logistic) service providers>
• Team player and able to work independent