9 jun 2026
Clinical Studies Manager (TEMP)
| Branche | Zie onder |
| Dienstverband | Zie onder |
| Uren | Zie onder |
| Locatie | Utrecht |
| Opleidingsniveau | HBO / bachelor |
| Contactpersoon |
Olawale Olukunga +31622258890 |
Informatie
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).
Omschrijving
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).
Functie eisen
Education
- Bachelor’s or Master’s degree in a life sciences or related scientific discipline
Knowledge
- Experience in (international) clinical study (product) management
- Familiar with ICH-GCP, GDP and GMP guidelines.
Skills
- Fluent in English (written and verbal), French is a plus
- 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
