Senior Clinical Study Manager

Research & Innovation

Senior Clinical Study Manager

(Utrecht, full-time, #hybrid)

Are you passionate to make a health difference through specialized nutrition by providing clinical expertise in the start-up and operational management of clinical studies? Do you get excited about contributing your knowledge and experience to deliver meaningful clinical evidence resulting in nutrition-based solutions that impact life?

Your mission: as Senior Clinical Study Manager (Sr CSM) you are 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 Sr CSM will work within the Clinical Research department at the Danone Global R&I center in Utrecht, NL. The Sr CSM will play a crucial role in the start-up and operational management of highly complex clinical studies. He/she will support the Senior Team Leader Clinical Studies in achieving the team deliverables and takes the lead in managing clinical studies, delegating tasks, driving changes, operational innovations, 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 Clinical Study Researchers, Clinical Study Assistants (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)
• Bringing new insights to the company with a pioneering mindset

About you

• A Master and/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 agile approaches
• Strong project management and passionate 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 Sr 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 Sr CSM is someone who shows leadership, takes a pro-active approach in his/her work, and can clearly contribute to further development of the team and the ways of working.

About Danone

At Danone, we offer a complete package of benefits, with a competitive primary salary and yearly bonus, but also benefits like a premium-free pension, 30 days annual leave, and several discounts on a collective health insurance and even on some of our products. In the Netherlands, we also offer a hybrid working environment which enables each team to meet our people's desire for flexibility. Across our 3 office hubs in Hoofddorp, Rijswijk, and Utrecht this helps us create better opportunities for connection & synergies across our entities, teams, functions, and categories.

Need more information? Please contact Claudia Llona, Talent Manager via claudia.llona@danone.com.

* all applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

Job details

Dedicated to bringing health through food to as many people as possible, we are a leading global food & beverage company built on four businesses: Essential Dairy and Plant-Based Products, Waters, Early Life Nutrition, and Medical Nutrition.