About the job
Your mission:
As a Clinical Study Manager (CSM) you will be responsible for the operational set up and management of clinical concept 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-Nutricia 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 work within the NCRU and Human Evidence Generation team of Nutricia Research and will report to the Sr TL 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 CSM will play a role in the operational set up, conduct and management of explorative clinical concept 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. Ready for this challenge? Apply today!
About you
The CSM will work within the NCRU and Human Evidence Generation team in Advanced Health & Science at Danone/Nutricia Research 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. Next to this you will also be responsible for:
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
We are looking for a Clinical Study Manager with:
A Master and/or PhD in life science or related scientific discipline
Experience (3+ years) in (international) clinical study operational management preferably in the conduct of clinical concept studies
Thorough knowledge of legislation and ICH-GCP guidelines
Strong project management and passionate leadership skills
Good writing and communication skills in 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 concept 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.
About us
Working here you’ll need to enjoy a fast-pace, complexity and it can get a little challenging. But it’s packed with opportunities. You’ll work with some of the best-known brands in the world, such as Evian, Nutricia, Activia and Nutrilon and we absolutely guarantee that you can just be yourself. Be innovative and entrepreneurial and the impact you could make might just amaze you. Join our movement for a healthier world. One Planet One Health BY YOU.
We are proud to be an equal employer. We are convinced our differences make the difference and that an inclusive working environment will drive our growth as a business, as teams and as individuals. We will therefore consider all applicants for employment* fostering an inclusive working culture that is accessible for all.
Did you know that as a B-Corp certified company, Danone Benelux meets the highest verified standards of social and environmental performance, transparency, and accountability?
We Offer
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, Zoetermeer 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.
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