Clinical Study Manager

One of our clients specialized in nutrition and localized in Utrecht is looking for a Clinical Study Manager. 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.

  • Do you have a master or phD in life sciences?
  • Do you have a solid experience in clinical research?
  • Do you have excellent communications skills in English?
  • Do you want to work 100%?

Then you are probably a suitable candidate for this job. Apply today to find out more!

Job Description 

The Clinical Study Manager will work within the Global ELN Center of Excellence Clinical Research. The CSM 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.

Responsibilities 

Some of the 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
Profile 

We are looking for a Clinical Study Manager with:

  • a 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

The ideal CSM is able to manage 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 connect effectively with various stakeholders inside the company but also externally with for instance CRO’s, central labs, sites and investigators. The CSM is someone who takes a pro-active approach in his work and can clearly distinguish main and side issues.

Contact Information 

Claire Aerts
+32 15 21 11 04
claire.aerts@valesta.com

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