Freelance Clinical Study Manager (ZZP)

Job descriptionY

acht 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 will work within the NCRU and Explorative clinical studies team, and will report to the Sr TL of this team. This team is responsible for the generation of clinical evidence on new concepts in different fields that may result in the future in new products for the market. The CSM will play a role in the operational set-up, conduct and management of explorative clinical studies, both internal in our clinical research unit, as well as with external sites. With your skills in clinical research, you will be responsible for establishing a smooth and efficient cooperation within the multidisciplinary study team, consisting of e.g., a Clinical Study Researcher, Data Manager, Statistician, Clinical Supplies Manager and Scientist.

About The Job:

The CSM will play an important role in the start-up and operational management of clinical studies. You will take the lead in managing clinical studies and will support in achieving the team deliverables.

Next to this, you will also be responsible for:

•       Ensure studies are set up and conducted in line with GCP

•       Arrange for regulatory and ethics submissions and approvals

•       Select clinical sites

•       Provide progress reporting (resources, budgets, timelines)

•       Day-to-day alignment with the study team

Key responsibilities are:

• Lead a multi-disciplinary clinical study team, which could consist of a Clinical Study Researcher, Clinical Study Assistant, Data Manager, Statistician, Clinical Study Supplies Manager, Medical Monitor, Quality Manager and Scientist, and establish a smooth and efficient cooperation

• Operational excellence in the set up and management of clinical studies

• Identify and/or manage the potential investigators and clinical sites, both nationally and internationally; conduct pre-study site visits, assess the operational feasibility of a study protocol, where needed arrange for regulatory and ethics submission and approval, supervise third parties, and in case of DSS, arrange or take part in initiation, monitoring and close out visits.

• Financial management of clinical projects, including monitoring of study budgets

• Ensure the clinical studies are within budget, timelines, and quality KPIs

• Influence and drive quality up to the internal standards within an DSS or ISS and/or Consortium context and ensure the studies are setup and conducted in line with GCP and regulatory requirements

• Provide progress reporting (resources, budgets, timelines, quality)

• Driving innovations within the team, pro-actively looking for new implementations and changing the course when necessary; bringing new insights to the company with a pioneering mindset

• Build and maintain internal and external network of Investigators and other stakeholders

Job requirements

We are looking for a Clinical Study Manager with:

• A Master and/or PhD in life science or related scientific discipline

• Experience (3+ years) in (international) clinical study operational management preferably in the conduct of clinical concept studies

• Thorough knowledge of legislation and ICH-GCP guidelines