Clinical Study Manager

(Utrecht, full-time, hybrid)

As a Clinical Study Manager (CSM) you will be responsible for the operational set up and management of clinical studies based on the latest scientific insights. In this role you will strengthen the clinical evidence for future growth opportunities for the business.  The clinical studies for which you will be responsible can be Danone Sponsored Studies (DSS) or Investigator Sponsored Studies (ISS) or conducted in an open innovation or consortium setting.  All to be done in accordance with the Clinical Study Plan, ICH-GCP, applicable legislation and Quality Management System.

The CSM will play a role in the operational set up, conduct and management of clinical studies, both internal in our clinical research unit, as well as in a hospital setting. With your skills in clinical research, you will be responsible for establishing a smooth and efficient cooperation within the multi-disciplinary study team, consisting of e.g., a Clinical Study Researcher, Data Manager, Statistician, Clinical Supplies Manager and Scientist. 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? Ready for this challenge?  Apply today!

About the job

The CSM will work within the Clinical Research department at the Danone Global R&I center in Utrecht, NL and will play an important role in the start-up and operational management of clinical studies. You will take the lead in managing clinical studies and will support in achieving the team deliverables. Your key focus areas will cover the following:

• Ensure studies are set up and conducted in line with GCP
• Arrange for regulatory and ethics submissions and approvals
• Select clinical sites
• Provide progress reporting (resources, budgets, timelines)
• Day-to-day alignment with the study team

Key responsibilities are:

• Lead a multi-disciplinary clinical study team, which could consist of a Clinical Study Researcher, Clinical Study Assistant, Data Manager, Statistician, Clinical Study Supplies Manager, Medical Monitor, Quality Manager and Scientist, and establish a smooth and efficient cooperation
• Operational excellence in the set up and management of clinical studies
• Identify and/or manage the potential investigators and clinical sites, both nationally and internationally; conduct pre-study site visits, assess the operational feasibility of a study protocol, where needed arrange for regulatory and ethics submission and approval, supervise third parties, and in case of DSS, arrange or take part in initiation, monitoring and close out visits.
• Financial management of clinical projects, including monitoring of study budgets
• Ensure the clinical studies are within budget, timelines, and quality KPIs
• Influence and drive quality up to the internal standards within an DSS or ISS and/or Consortium context and ensure the studies are setup and conducted in line with GCP and regulatory requirements
• 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 Investigators and other stakeholders

• A Master and/or PhD in life science or related scientific discipline
• Experience (3+ years) in (international) clinical study operational management
• Thorough knowledge of legislation and ICH-GCP guidelines
• Strong project management and passionate leadership skills
• Good writing and communication skills in Dutch and English and good influencing skills to interact with internal and external stakeholders
• Ability to solve challenges with unique agile approaches

The ideal CSM can take the lead in managing clinical studies in various stages from start-up to overall progress and reporting for the clinical study operational part. He/she can develop study documents required for METC approval. 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 can influence effectively with various stakeholders inside Danone but also externally with for instance study sites, (central) labs and investigators and is someone who takes a pro-active approach in his/her work.

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.

What’s next?

Hit the “apply now” button. After your application deadline first feedback will follow within 2 weeks. In case you are invited to the selection process you should expect to receive feedback 2 weeks after each step of the process

To comply with GDPR regulations, we cannot process your personal data without given consent. Therefore, we strongly recommend applying directly via our website.

Need more information? Please contact Valerija Usova, Talent Manager via valerija.usova@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.