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Clinical Study Manager
A multinational food company is looking for a Clinical Study Manager
De functie / The role
The clinical study manager is responsible for the operational management of clinical research projects, including start-up, overall progress and reporting of the clinical studies, all in according with the Clinical Study Plan, ICH-GCP, applicable legislation and Standard Operating Procedures.
The Clinical Study Manager will play a crucial role in the start-up and operational management of the clinical studies. He/she will be responsible for translating the clinical study protocol into the clinical study plan and ensures that good quality data will be collected. The CSM brings his expertise into the clinical studies, has a helicopter-view on how the studies are developing and will include colleagues or stakeholders where needed.
Other key responsibilities are:
Establish a smooth cooperation within the multi-disciplinary project team, consisting of CSR"s, CSA"s, Data Management, Supplies, Quality and Science.
Ensure 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).
Day-to-day alignment with the team members.
Het profiel / Your profile
Master or PhD in life science or related scientific discipline
Solid experience in (international) clinical research in an academic setting or the (bio-) pharmaceutical industry
Thorough knowledge of legislation and ICH-GCP guidelines
Project management skills
Excellent communication skills in English to interact with internal and external stakeholders
Problem solving and critical thinking capabilities