Working within the early life medical affairs and nutritional science category team, you will use your methodological and scientific expertise in different phases of a clinical study in humans ranging from the early phase of translating business needs in the right study design to writing the clinical study report and being involved in writing scientific publications. As a Clinical Study (CS) Researcher you will have a key role in designing the study, writing the protocol, developing statistical analysis plans, interpreting results, and writing clinical study reports. You will work in close collaboration with Scientists, CS Managers, Data Managers and Statisticians, as well as other stakeholders within Danone Nutricia Research to ensure the right data is collected.
MAIN RESPONSABILITIES:
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Business Strategy/Vision:- Understand & contribute to the scientific strategic roadmaps and execute this strategy through efficient project contribution.
Impact on Business Results:
- Business impact by ensuring high-quality design and execution of clinical studies to ensure evidence on our research and products and ensuring compliance to regulatory requirements.
- Process & Projects
- Expert on clinical study methodology, study design, protocols, interpretation of results
- Clinical Research Community engagement
Managerial Complexity:
- Able to navigate a complex environment of internal stakeholders in varying teams, levels and disciplines.
- Writing/involvement in different studies at the same time with different sponsors from CoE's.
- Partners and stakeholders from R&I globally
KEY DELIVERABLES FOR THIS ROLE WOULD INCLUDE:
- Translating business needs and existing clinical and literature data into adequate and accurate study designs to support the innovation pipeline of products within the early life team
- Writing study protocol and assess scientific feasibility of a study with respect to subject population
- Writing the scientific part of a statistical analysis plan
- Interpretation of results, writing the clinical study report and contribute to scientific publications
- Safeguard the quality of the study
- Collaboration with science teams and clinical study teams
- Build and maintain internal and external network of KOL's specialising in allergy and immunology
About you
About you
INNOVATION SKILLS & COMPETENCIES:
- Profound experience in clinical research in an academic setting or the (bio-) pharmaceutical industry
- Knowledge and experience with ICH-GCP guidelines, legislation and SOPs relating to clinical studies.
- Medical writing skills and/or familiar with medical terminology
- Pragmatic attitude and be adaptable to the changing needs of the business
EDUCATION/EXPERIENCE:
- Education: Master preferred, Bachelor
- Experience: up to 3 years
About us
About us
Working at Danone is a unique experience. It’s fast-paced and complex and, at times, it can get a little challenging. But it’s packed with opportunities to learn and grow working with some of the best-known brands in the world, like Evian, Alpro, Nutricia, Activia and Nutrilon. Bring your unique perspective, ambitions and entrepreneurial ideas to the table – the impact you could make might just surprise you. One Planet. One Health – BY YOU.
We’re proud to be a B-Corp certified company. That means we meet the highest verified standards of social and environmental performance, transparency, and accountability in everything we do.
We’re committed to building a diverse and inclusive team. As an Equal Opportunities Employer, we base our hiring decisions on merit, job requirements and business needs.*
We offer
It’s an exciting time to join Danone as a Clinical Study Researcher - Early Life. You’ll build meaningful strategy in this new created position. And the best part? You’ll be supported to grow an impactful career that you can be proud of. Together, we’ll build a healthier world.
All Danoners receive a complete package of benefits. This includes a competitive salary and yearly bonus, a premium free pension and great discounts on health insurance and Danone products. We understand the importance of flexibility and offer 30 days of annual leave (with the opportunity to purchase more) and a hybrid working environment, where you can work either from home or from one of our People Hubs in Hoofddorp, Utrecht and Zoetermeer.
What’s next
It’s simple – hit the “apply” button. In order to comply with GDPR we can’t process your personal data without your given consent, so please apply directly via this website. Good luck! We can’t wait to meet you.
Need more information?
Please contact Olivier de Ranitz (Talent Acquisition Manager) via Olivier.de-Ranitz@external.danone.com
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