Clinical Study Manager

Short Intro and About the Job The Clinical Study Manager works within the Clinical Evidence Early Life Team of Danone Global Research & Innovation Center. The CSM plays a crucial role in the end-to-end operational planning and management of clinical studies. He/she (co-)leads the management of clinical studies within a cross-functional team and drives quality, changes and improvements within the team and projects.

The CSM (co-)leads the operational management of clinical studies from early design through reporting and publication. He/she translates legislation and ICH-GCP requirements into pragmatic, hands-on solutions while carefully managing quality and associated risks. He/she effectively influences and engages a broad range of internal stakeholders, including cross-functional teams and Country Business Units, and external partners, such as CROs/ CRAs, central laboratories, study sites, investigators and Key Opinion Leaders.

The CSM demonstrates leadership, works proactively and drives continuous improvement in ways of working.

Key tasks / responsibilities

• Establishing a smooth and efficient collaboration within the multi-disciplinary internal project team, consisting of e.g. Clinical Study Researchers, Clinical Study Assistants, Supplies Managers, Data Managers, Medical Monitors, Statisticians and Quality Managers Ensure clinical studies are set up and conducted in line with GCP and applicable Regulatory requirements Arrange for Ethics and applicable Regulatory submissions & approvals Select, collaborate with and monitor activities of external clinical partners (CRO’s/CRA’s, sites) Provide progress reporting, highlight/mitigate risks related to quality, timelines, budget and resources and ensure timely escalation where necessary About You You will work within the Clinical Evidence Early Life team at Danone Global Research & Innovation and collaborate closely with multidisciplinary project teams.
• The role involves extensive interaction with internal stakeholders, including Country Business Units and colleagues across clinical research, data management, medical, statistics and quality, as well as external clinical research partners.
• You bring a proactive and pragmatic approach, are comfortable working across different stakeholders and can combine clinical research expertise with effective project management.
• Must-haves A Master’s degree and/or PhD in Life Sciences or a related scientific discipline.
• Solid clinical research experience, with approximately five years of experience in clinical project management.
• Thorough knowledge of relevant legislation and ICH-GCP guidelines.
• Good project management and leadership skills.
• Excellent communication skills in English, strong stakeholder engagement and influencing skills, and pragmatic problem-solving and critical-thinking capabilities.
• About Us, We offer and What's next At Danone we are committed to our mission “bringing health, through food to as many people as possible”.
• We are working together to make sure that our brands, like Nutricia and Nutrilon, create real benefits for people, communities and the planet.
• You will be part of one of the largest Certified B Corps™ in the world.
• Being B Corp means to be part of a select movement of companies verified to be meeting the highest standards of social and environmental criteria and using business as a force for good.
• One Planet.
• One Health.
• Our state-of-the-art research and innovation center builds bridges between food and science and is global in reach, founded on over 125 years of experience in life & food science, technology and user experience and is at the forefront of pioneering advances in specialized nutrition.

We offer

• All Danoners receive a complete package of benefits.
• This includes a competitive salary and yearly bonus, a premium free pension, 30 days of annual leave (with the opportunity to purchase more) and you will receive a monthly health care allowance.
• In addition, you can get discount on your gym membership, and we offer initiatives focused on nutrition, physical, and mental health.
• We provide continuous learning opportunities through workshops, online courses and training sessions.
• We put people at the center of everything we do.
• Bring your unique perspective, ambitions and ideas to the table – the impact you could make might surprise you.
• We are committed to embrace diversity, nurturing an inclusive workplace where every individual is valued; Diversity, Equity, and Inclusion (DEI) is deeply embedded in Danone's DNA.

What's next

It’s simple – hit the “apply” button before the application deadline of 9 November. 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 Robin Hiariej. * All applications will be considered for a vacancy without discrimination based on ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristic protected by law. #LI-NL #LI-HYBRID