Senior Clinical Study Manager Gut Health
Are you passionate to make a difference through nutrition for infants, mothers and families by providing clinical expertise in the performance of clinical studies? Do you get excited by contributing your clinical research expertise to Danone’s mission: bringing health through food to as many people as possible?
About the Job
The Senior CSM Gut Health 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 of Gut Health in achieving the team deliverables and takes the lead in managing clinical studies, delegating tasks, driving changes and improvements within the team and projects. In this role you will:
- Establish a smooth and efficient cooperation within the multi-disciplinary project team, consisting of CSR’s, CSA’s, Data Management, Supplies, Quality and Science
- Drive 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, third parties/vendors (CRO’s/ sites)
- Provide progress reporting (resources, budgets, timelines)
- Contribute to business strategy and apply it into your project(s)
- Ensure Day-to-day alignment with the team members (mentor CSAs and other CSMs)
The ideal Senior CSM Gut Health is an entrepreneur who is able to take the lead in managing clinical studies in various stages from start-up to overall progress and reporting. You know how to translate a research question into a clinical study in line with applicable legislation and ICH-GCP, using a pragmatic and hands-on approach, while staying conscious of the risks involved. You can 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. The ideal candidate for this role has:
- 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
Danone’s mission is bringing health through food to as many people as possible and we want to invite people to join the movement for a healthier world. We recognize the power people have to impact the world through their daily choices. Healthy food needs a healthy planet, and this is what our new signature One Planet One Health embodies.
The role of Senior Clinical Study Manager Gut Health is positioned in the team of Namkje van der Laan within the Global ELN Center of Excellence Clinical Research at Danone Nutricia in Utrecht. This team 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. In this role you will work closely together with colleagues as Heidi Sonnemans and Gerda van Wijhe.
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, several discounts on a collective health insurance and even on some of our products. But more importantly – this is a unique opportunity to bring a lot of value into Danone were future possibilities are discussed based on your personal development needs.
Hit the “apply now” button. You have until the closing date of November 25th 2018 to apply. Need more information? please contact Ingrid Cusiel (Head of Talent R&I) on firstname.lastname@example.org or via +31 6 46 86 96 99. Please be aware that applications are only taken in consideration via LinkedIn or jobs.danone.com. To comply with GDPR regulations, we cannot process your personal data without given consent. Therefore, we strongly recommend applying directly via our careers website.
Experience: Experienced Professionals