Job Description
Yacht Life Sciences has an opportunity for a Clinical Study Manager at 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:
As clinical study manager you are responsible for the operational management of clinical research projects, including start-up, overall progress and reporting of the clinical studies, all in accordance with the Clinical Study Plan, ICH-GCP, applicable legislation and Standard Operating Procedures.
The CSM will work within the Clinical Research Operations group of the Specialized Nutrition Unit at this International Food Innovation Company. The CSM will play a crucial role in the start-up and operational management of clinical studies. He/she will take the lead in managing clinical studies or is a member of the study team. The CS Manager has clear leadership skills, and is able to act, decide and escalate autonomously and supports the Team Leader Clinical Studies in achieving the team deliverables.

Other key responsibilities are:
•   Establishing a smooth and efficient cooperation within the multi-disciplinary project team, consisting of Clinical Study Researchers, Clinical Study Assistants (CSA’s), Data Management, Supplies, Quality and Science
•       Pro-actively looking for new implementations and changing the course when necessary
•       Ensure studies are set up and conducted in line with Good Clinical Practice (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)
•       Apply business strategy into the project
•       Day-to-day alignment with the team members