Senior Clinical Study Manager
About Danone and our mission
Danone is a multinational food company dedicated to bringing health through food to as many people as possible. This mission guides our 2,250 “Danoners” in the Netherlands and more than 100,000 worldwide on an everyday basis.
Nutricia Research is part of Danone. R&D is an important basis of the work we do in nutrition and health. We collaborate with partners, for example in academia, suppliers and healthcare, we aim to identify new nutritional intervention opportunities and develop innovative product forms. Our largest innovation center is located in Utrecht Science Park, the Netherlands. It is a state-of-the-art center for the development of new nutritional product concepts for Early Life Nutrition and Advanced Medical Nutrition. We create products that provide clinically proven health benefits to vulnerable consumers – infants, toddlers, expecting mothers, the elderly and patients.
The Senior clinical study manager is responsible for the operational management of (complex) clinical research projects, including start-up, overall progress and reporting of the clinical studies, all in accordance with the Clinical Study Plan, ICH-GCP, applicable legislation and Standard Operating Procedures.
The Senior Clinical Study Manager will work within the Global ELN Center of Excellence Clinical Research. There are 2 roles available: one within the team of Namkje van der Laan (Clinical Program Leader Gut Health) and the other in the team of Heidi Sonnemans (Clinical Program Leader Allergy). The Senior CSM will play a crucial role in the start-up and operational management of highly complex clinical studies. He/she will support the Clinical Program Leader in achieving the team deliverables and takes the lead in managing clinical studies, delegating tasks,driving changes and improvements within the team and projects.
Other key responsibilities are:
- Establishing a smooth and efficient cooperation within the multi-disciplinary project team, consisting of CSR’s, CSA’s, Data Management, Supplies, Quality and Science
- Driving innovations within the team, pro-actively looking for new implementations and changing the course when necessary
- Ensure highly complex studies are set up and conducted in line with GCP
- Arrange for regulatory and ethics submissions and approvals
- Select, collaborate with and monitor activities of clinical partners (CRO’s/ sites)
- Provide progress reporting (resources, budgets, timelines)
- Contribute to business strategy and apply it into project
- Day-to-day alignment with the team members (mentor CSAs and other CSMs)
We are looking for a Senior Clinical Study Manager with:
- a Master or PhD in life science or related scientific discipline
- extensive experience in (international) clinical research
- thorough knowledge of legislation and ICH-GCP guidelines
- Ability to solve complex challenges with unique approaches
- Strong project management and leadership skills
- Excellent communication skills in English and solid influencing skills to interact with internal and external stakeholders
- Problem solving and critical thinking capabilities
The ideal Senior CSM is able to take the lead in managing clinical studies in various stages from start-up to overall progress and reporting. He/she knows how to translate legislation and ICH-GCP into a pragmatic and hands-on approach, while staying conscious of the risks involved. He/she is able to influence effectively with various stakeholders inside Danone but also externally with for instance CRO’s, central labs, sites, investigators and Key Opinion Leaders. The Senior CSM is someone who shows leadership, takes a pro-active approach in his work and can clearly contribute to further development of the team and the ways of working.
Are you the Senior Clinical Study Manager we are looking for?
If you have any question about the position or the recruitment procedure, please contact Ingrid Cusiel (Head of Talent R&I) via + 31 (0)6 46 86 96 99 or email@example.com. If you are interested, please apply before the 27th of August 2018 via our corporate website jobs.danone.com. Applications via email will not be processed. Interviews will be scheduled after the holidays, early September 2018. If you have a preference for one of the two programs (Gut Health or Allergy), please mention that in your cover letter.