Project Compliance Manager - Utrecht

Function Group: Clinical Research / Clinical Quality Auditor


For a mid-sized CRO active in pharmaceutical and medical devices studies, we are searching for a Project Compliance Manager. Within this role you have great impact on the success of the projects since you will be in-lead to shape and execute the compliance aspect of the in the project team. This organisation strives for short communication lines, a personal approach and innovation towards their clients.


Within this role you will be responsible for the compliance with the quality requirements and standards of the trials. This will be achieved through your compliance management on the processes, tools, reports, and systems that are used in the trials. By developing standardised processes, ensuring these processes are correctly implemented and offering support to the involved parties for implementation and correct compliance. Moreover, you will ensure the overall quality of the trials and client satisfaction.

Additionally, you will act as the primary contact for any escalation of issues, stay up-to-date on any new technologies or training, initiate updates on processes, be responsible for compliance checks, analyse findings of these checks, propose corrective and preventive actions, and initiate these actions when approved.


  • Higher education in a (bio)medical field
  • Extensive and highly up-to-date knowledge on ICH-GCP guidelines, legislation and regulations, clinical processes, and industry practices
  • More than five years of experience in a Clinical role
  • Fluent, both written and spoken, in Dutch and English
  • Pre: Experience in training and harmonising study processes


  • Chance to develop yourself and your career in an international environment
  • A flexible and open work culture with short management lines
  • An easily accessible office
  • A competitive salary


If you are interested in this job, or in similar ones, please feel free to contact me directly.

Saskia Cepella
Consultant Clinical Research | Medical Devices


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