Clinical Study Manager

Job description

AT A GLANCE, YOU WILL

Experience #lifeatdanone

Work with many brands

About the job

The Medical & Nutritional Science department is hiring anExploClinical Study Manageron a permanent contract in theClinical Research & Health Data team. The position is based in Gif-sur-Yvette (91) on theSaclayplateau in the Danone Global Research & Innovation Center Daniel Carasso Centre which is at the heart of Danone Research & Innovation. Itcompriseslaboratories and pilot workshops at thecutting edgeof science and technology, with employees working collectively to innovate on the dairy and plant products,watersandspecializednutrition of tomorrow.   

The Medical & Nutritional Science R&I division aims to create value and growth opportunities for Danone around Nutrition and/or Health. 

 

Within Danone's Clinical Research team, the Clinical Study Manager is responsible for the launch and operational execution of clinical studies in the Dairy and Plant-Based categories.

 

Missions : 

·  Coordinate a multidisciplinary project team and establish fluid and efficient cooperation.
Ensure operational excellence in the construction and management of clinical studies.
·  Depending on the study, is responsible for, supervise and/or contribute to the development of the clinical study protocol, participate in the choice of methodology, co-construct the protocol, study documents, statistical analysis plan, interpretation of study results and drafting of the study report;
·  Identifying and/or managing investigators and clinical sites, assessing the scientific feasibility of a study protocol, organising regulatory and ethical submission and approval, supervising third parties (e.g. CROs) and participating in opening and closing visits.
Manage the quality of DSS and ISS studies to ensure compliance with Danone standards and that studies are set up and conducted in accordance with GCP and regulatory requirements.
Build and maintain an internal and external network of key opinion leaders, investigators, experts and other stakeholders.
·  Contributing to Danone's research and business strategy and translating it into projects through targeted decisions.

 

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About you

Must have : 

·  Master's degree (bac+5) or engineering degree and/or PhD in life sciences or related scientific discipline.
·  Experience in the operations and methodology of (international) clinical studies and initial experience in setting up and conducting exploratory/proof-of-concept studies (3-5 years)
·  In-depth knowledge of the legislation and regulations applicable to clinical studies (ICH-GCP)
·  Ability to solve complex challenges with an agile approach and a critical eye
·  Project management skills
·  Organisational skills, autonomy, flexibility, proactivity
·  Excellent communication and interpersonal skills
Fluent French and English

 

Nice to have : 

·  Knowledge of nutrition, agri-food, intestinal microbiota and probiotics
·  Leadership experience
·  Curiosity and interest in gut microbiota research

About us

At Danone, we guarantee that you can simply be yourself. We believe thatit'sup to you to define the way you work, to develop yourself, to progress. With us,you'llwork in an exciting,complexand challenging environment. This is how you will create new opportunities! You will work with world-renowned brands such asBlédina, Evian or Actimel. Be innovative, enterprising and the impact you will have will impress you. Join our movement for a more sustainable world. One Planet One Health BY YOU. 

If you want to know more about our news, our dailylifeand our teams, follow our adventures on our Instagram account @DanoneTalentFrance !