Clinical Study Manager

Bedrijfsomschrijving

About the company

Our client has worldwide R&D facilities and established a new research & innovation centre at the Utrecht Science Park.

You will work in a life sciences innovation centre for the development of new product concepts for Baby Nutrition and Medical Nutrition. They create formulas that provide clinically substantiated health benefits to vulnerable consumers - infants, toddlers, elderly and patients. Capitalizing on their numerous international pre-clinical and clinical collaborations, they aim to identify new nutritional intervention opportunities and develop innovative product forms.

Job description

Yacht Life Sciences has an opportunity for a Clinical Study Manager at an International Food Innovation Company situated in Utrecht, the Netherlands.

Are you passionate to make a health difference through specialized nutrition by providing clinical expertise in the start-up and operational management of clinical studies? Then you should let us know!

Your mission:

The CSM works within the Clinical Research department. The CSM plays a crucial role in the start-up and operational management of highly complex clinical studies led by the Global Clinical Research team. He/she supports the leadership team in achieving the team deliverables and takes the lead in managing clinical studies, delegating tasks, driving changes, operational innovations and improvements within the team and projects.

Next to that, the CSM will provide consulting activities related to the set-up and conduct of clinical studies conducted by the local Country Business Units (CBUs) within our client. Consulting activities include but are not limited to sharing best practices, reviewing and proposing improvements to protocol and any supporting documents, outlining and support with clinical study specific processes (eg. 3rd party selection, support in CRO oversight, risk management, input in contracts, site selection and start-up).

The CSM is able to take the lead in managing clinical studies in various stages from start-up to overall progress and reporting:

• He/she knows how to translate legislation and ICH-GCP into a pragmatic and hands-on approach, while staying conscious of the risks involved.
• He/she is able to influence effectively with various stakeholders inside the company, but also externally with for instance CRO's, central labs, sites, investigators and Key Opinion Leaders.
• The CSM is someone who shows leadership, takes a proactive approach in his/ her work and can clearly contribute to further development of the team and the ways of working.

Other key tasks / responsibilities:

• Establishing a smooth and efficient collaboration within the multidisciplinary project team, consisting of Clinical Study Researchers, Clinical Study Assistants (CSA's), Data Management, Supplies, Quality and Science and for selected projects also with the Country Business Units (CBUs) and Global Medical Affairs teams.
• Driving innovations within the team, proactively 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 (CRO's/ sites)
• Provide progress reporting (resources, budgets, timelines)
• Contribute to business strategy and apply it into project
• Day-to-day alignment with the team members
• Bringing new insights to the company with a pioneering mindset
• Ensure studies are set up and conducted in line with Good Clinical Practice (GCP)

Job requirements

We are looking for a Clinical Study Manager with:

• A Master and/or PhD in life science or related scientific discipline
• Extensive experience in (international) clinical research
• Thorough knowledge of legislation and ICH-GCP guidelines
• Previous work experience in a consultancy role
• Ability to solve complex challenges with unique agile approaches
• Ability to share knowledge and expertise with different stakeholder levels

Terms of employment

This concerns a temporary secondment contract for 1 year (extension is possible), full-time is preferred (36 hours per week can be discussed). We will offer a salary in line with the seniority of the position.

Working remote is possible (with 1-2 days per week working on-site).

Freelance candidates are also welcome to apply for this role.

You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.