The Medical & Nutritional Science department is hiring a Clinical Study Research (CSR) on a permanent contract in the Clinical Evidence & Health Data team. The position is based in Gif-sur-Yvette (91) on the Saclay plateau in the Danone Global Research & Innovation Center Daniel Carasso Centre which is at the heart of Danone Research & Innovation. It comprises laboratories and pilot workshops at the cutting edge of science and technology, with employees working collectively to innovate on the dairy and plant-based products, waters and specialized nutrition of tomorrow.
The Medical & Nutritional Science R&I division aims to create value and growth opportunities for Danone around Nutrition and/or Health.
The CSR is responsible for the methodology and scientific rationale of clinical studies related to the FMCG (Fast Moving Consumer Goods) category, covering Dairy and Plant-Based Products. The objective of this role is to contribute to strengthening the clinical evidence supporting the concepts on which Danone is working as future growth opportunities for the company.
The studies may be sponsored by Danone or by independent investigators. The CSR is required to work in compliance with the predefined project plan, Good Clinical Practice (ICH-GCP), applicable regulations, and the quality management system.
The CSR will work within Danone’s “FMCG Clinical Evidence” team and will report to the FMCG Biotics Clinical Team Leader (TL). This team is responsible for generating clinical evidence for the FMCG category. The CSR will play a scientific and clinical methodological role, including the review of the scientific literature, the preparation of protocols for studies, the conduct of data reviews, and the interpretation of clinical study results.
• Ensure the relevance of the scientific rationale of the studies and its alignment with business needs and consumer expectations.
• Contribute to Danone’s research and business strategy and translate it into projects through informed, strategic decision-making.
• Coordinate a multidisciplinary project team, which may include a scientist, a statistician, a data manager, an analytical project manager, a clinical product manager, a medical monitor, and a quality manager, and establish smooth and effective collaboration.
• Depending on the specific requirements of a given study:
o oversee and contribute to the development of the clinical study protocol, participate in the selection of the methodology, and co-develop with the project team, investigators, scientists, and statistician(s) the protocol, study documents, statistical analysis plan, interpretation of study results, and the drafting of the study report;
• Build and maintain an internal and external network of key opinion leaders, investigators, experts, and other stakeholders.
The ideal CSR can lead scientific and methodological discussions that are instrumental in the development of study protocols and other key documents (clinical evidence plan, statistical analysis plan, data review meeting reports, study results and study report). When necessary, he/she can draft all or part of clinical study protocols and exploratory study reports using templates from previously conducted studies.
He/she can translate regulatory requirements and ICH-GCP into a pragmatic and practical approach, while remaining aware of the associated risks. He/she can effectively influence a wide range of stakeholders both within Danone and externally, for example study sites, investigators, and key opinion leaders.
The CSR demonstrates leadership, adopts a proactive approach to his/her work, and can clearly contribute to the further development of the team and its ways of working.
Must have:
• Master’s degree (Bac +5) or engineering degree and/or PhD in Life Sciences or a related scientific discipline
• Experience in clinical study operations and methodology (including international studies), with initial experience in clinical research (exploratory / proof-of-concept studies) (3–5 years)
• Knowledge of legislation and regulations applicable to clinical studies in humans (ICH-GCP, GDPR)
• Ability to address complex challenges with an agile approach and a critical mindset
• Project management skills combined with strong, passionate leadership
• Strong organizational skills, autonomy, flexibility, and proactivity (ability to prioritize and escalate when needed)
• Strong interest in developing and drafting clinical documents
• Excellent communication and interpersonal skills to facilitate effective internal and external interactions
• Fluent in French and English
Nice to have:
Danone is proud to promote inclusion and equal opportunities. We truly believe that our diversity will make the difference and that an inclusive environment will make us grow as a company, as a team, and as people. We therefore consider all applications* to ensure an inclusive corporate culture where everyone can feel like they belong.
*All applications will be considered irrespective of origins and ethnicity, personal background, religion, gender, sexual orientation, age, disability....
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