Clinical Studies Manager (TEMP)
About this role
- 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).
Requirements
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
Salary
Through our agency, you will receive a 4 -month temporary contract. There is a possibility that your contract will be renewed after these 4 months or that our client will make you an offer of a contract, however, we are not able to guarantee this.
- Salary will be around €5000 - 6000 gross a month based on a full-time position (40 hours a week) and is based on education and experience;
- Travel expenses will be covered;
- Pension plan.
What will happen when you apply? Within four working days, we will let you know whether you are qualified for the position. If you do we will schedule an interview (digital or live). In this interview, we will inform you about the vacancy, the company, and the procedure. If we both agree this is a fitting opportunity we will introduce you to our client and continue to guide you through the whole application process. The Independent Recruiters Group has a large team of specialized recruitment consultants. Every recruiter has a strong focus regarding his/her field of expertise. This makes them the ideal sparring partner for both you, as the candidate, and the client.