Clinical Project Leader, medical device company

We are actively recruiting for one of our clients in the medical device industry.

Purpose of the job as Clinical Project Manager is to intiate, pilot and analyse epidemiologic studies and clinical trials.

  • Do you have experience in clinical investigation?
  • Are you fluent in a local language and fluent in English?
  • Are you accurate and well-organized?

Then this might just be the job for you? Don't hesitate, read more and apply as soon as you can!

 

 

Responsibilities 
  • Initiate and follow up clinical trials at the investigators
  • Remain compliant with the rules of the European Board:
    • Supervise protocol set up
    • Make follow up visits (patient enrolment objectives) to the investigator centers; audit the running of the study and the inclusion and exclusion criteria
    • Make visits at the launching and closing of the investigation centers
  • Help with implantation and follow up of the requirements in the framework of the studies
    • Analyze the results
    • Review observation notebooks
    • Manage the data base, present the results of the studies
    • Write study reports
  • Manage and coordinate communications, write resumes
    • Participate in the editing articles and generally publish the results to the people and groups concerned
    • Write articles for publication
    • Help with production of posters
  • Develop and coordinate regional and national clinical studies
    • Choose the experience plan the best adapted to the problem and ethical, deontological, regulatory and legal constraints related to a healthy or sick person
    • Write the protocol in line with the objectives of the studies, the problem formulated and good clinical practice
    • Communicate regularly with the EMEAC Clinical department.  Participate in quarterly clinical meetings organized by EMEAC
    • Ensure administrative, legal and regulatory steps are taken correctly
  • Monitor bibliographies
  • Maintain and develop a network of Key Opinion Leaders on a clinical basis, audit the centers to ensure they are in line with good clinical practice, influence the choice of investigator centers.
  • Manage the activity of CRAs reporting to the position.
  • Any other mission and tasks requested by the supervisor related to clinical studies

 

Profile 
  • Biomedical Engineer, or other scientific university degree
  • Experience in clinical investigation in pharmaceutical or medical device industry- Experience in the biomedical field
  • Local language fluent - English fluent
  • Computer knowledge
  • Knowledge of good clinical practice
  • Accurate, well-organized, technical, able to work alone
Contact Information 

Henk Van den Berg
+31 20 757 06 25
henk.vandenberg@valesta.com

Application form : Clinical Project Leader, medical device company

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