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Clinical Study Manager
Yacht Life Sciences has an opportunity for a Clinical Study Manager at an International Food Innovation Company situated in Utrecht, the Netherlands.
The CSM will work within the NCRU and Human Evidence Generation team of Danone Nutricia Research (Utrecht) and will report to the Senior Team Lead of the team. This team is responsible for the generation of clinical evidence on new concepts in different fields that may result in the future in new products for the market. The team is responsible for the methodological and operational set up, conduct and management, and results reporting of explorative clinical concept studies, both conducted internal in our clinical research unit, as well as in a hospital setting. The CSM’s in the team play an important role in the start-up and operational management of these clinical studies.
You will be responsible for:
- Set up and study/site management of Danone Sponsored studies and/or Investigator Sponsored studies
- Some on site monitoring may be part of this job
Next to this you will also be responsible for the following:
- Ensure studies are set up and conducted in line with GCP
- Arrange for regulatory and ethics submissions and approvals, including document writing, e.g. subject information sheets and manuals
- Select clinical sites
- Lead the multi-disciplinary study team consisting of e.g., a Clinical Study Researcher, Data Manager, Statistician, Clinical Supplies Manager, Product Developer and Scientist
- Arrange contracts in collaboration with the Legal team
- Ensure the clinical studies within budget, timelines and quality KPIs
- Provide progress reporting (resources, budgets, timelines)
Functie-eisen
- Bachelor or Master in life science or related scientific discipline
- > 4 years of experience in (international) clinical study operations and having affinity with the set up and conduct of explorative (proof of concept) studies
- Thorough knowledge of legislation and ICH-GCP guidelines
- Excellent communication skills in English and solid influencing skills to interact with internal and external stakeholders
Competenties
- Ability to solve challenges with a pragmatic and hands-on approach, while staying conscious of the risks involved
- Strong project management and passionate leadership skills
- Ability to manage multiple projects at the same time
- Problem solving and critical thinking capabilities
Arbeidsvoorwaarden
This concerns a temporary secondment contract till the end of the year (extension is possible), for 32 hours per week. We will offer a salary in line with the seniority of the position, with a full-time salary between 4500 and 5500 euro gross per 4 week period (based on full-time employment, 40 hours per week).You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
Bedrijfsinformatie
Our client has worldwide R&D facilities and established a new research & innovation centre at the Utrecht Science Park.You will work in a life sciences innovation centre for the development of new product concepts for Baby Nutrition and Medical Nutrition. They create formulas that provide clinically substantiated health benefits to vulnerable consumers – infants, toddlers, elderly and patients. Capitalizing on their numerous international pre-clinical and clinical collaborations, they aim to identify new nutritional intervention opportunities and develop innovative product forms.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.meer...
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