Nutrition Clinical Research Unit (NCRU) Manager

As a Nutrition Clinical Research Unit Manager (NCRU Manager) you will be responsible for the set-up, conduct and management of clinical studies performed in our Nutrition Clinical Research Unit (NCRU). In this role you will strengthen the clinical evidence for future growth opportunities for the business. All to be done in accordance with the Clinical Study Protocol, ICH-GCP, applicable legislation and the Quality Management System.

About The Job

The NCRU manager will work within the ‘NCRU and Explorative studies team’ of Danone Global R&I and will report to the Sr NCRU Manager of this 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 NCRU manager will play a role in the operational set up, conduct and management of clinical studies in our in-house clinical research unit. With your skills in a clinical unit setting, you will be responsible for establishing a smooth and efficient collaboration with the Clinical Research team (e.g. Clinical Study Manager, Clinical Study Researcher, Data Manager, Medical Monitor) and other internal teams (e.g. quality, facilities, logistics, biobank), but also with external suppliers (e.g. payroll company, subject recruitment company, equipment maintenance).

Your day-to-day activities will consist of:

• Operational set-up, planning and logistics of clinical studies performed in the NCRU
• Preparation of study-specific documents and procedures
• Interaction with study participants, e.g. (involvement in) conduct of study visits and calls
• Day to day management and coordination of the NCRU clinical studies
• First point of contact for medical staff and NCRU assistants
• Collaboration with the Clinical Research team and other internal departments
• Maintenance of the NCRU Quality Management System
• Training of NCRU staff on the NCRU Quality Management System and study procedures
• Maintenance and access to applicable information systems
• Basic lab activities (e.g. aliquotation of samples)
• Contribute to innovation and digitalisation of operational clinical research aspects

Your key responsibilities are:

• Contribute to the set-up and development of clinical studies
• Conduct NCRU clinical studies according to study protocol and NCRU procedures
• Deliver high quality clinical study results
• Build bridges between science and operational practice: Advocate the importance of operational feasibility and participant centricity in the development of clinical studies
• Create safe environment for study participants
• Accurate and complete clinical study administration
• Ensure the clinical studies are within budget, timelines, and quality KPIs
• Influence and drive quality up to the internal standards and in line with GCP
• Provide progress reporting (resources, budgets, timelines, quality)
• Driving innovations within the team, pro-actively looking for new implementations and changing the course when necessary; bringing new insights to the company with a pioneering mindset
• Build and maintain internal and external network of stakeholders

About you

We are looking for a NCRU Manager with:

• A Bachelor and/or Master in life science or related scientific discipline
• Experience (3+ years) in clinical study operational management in a clinical unit setting
• Thorough knowledge of legislation and ICH-GCP guidelines
• Strong project management and passionate leadership skills
• Excellent Dutch and English skills (spoken and written) and good influencing skills to interact with internal and external stakeholders
• Excellent social skills
• A ‘participant centric’ mind-set and ‘can-do’ mentality
• Ability to solve challenges with unique agile approaches
• Experience with digital applications or tools in clinical research is an advantage
• Experience with clinical research in the field of exercise and physical activity is an advantage
• Experience with basic lab work is an advantage