Clinical Research Project Manager

Posted on Oct 15, 2020 by Consol Partners

Leuven, Vlaams-Brabant, Belgium
Engineering
Immediate Start
Annual Salary
Contract/Project


Clinical Research Project Manager


Leuven, Belgium


6 month contract (extendable)


The assignment


Our client are developing a radically innovative testing solution for airborne infectious diseases. When this technology is rolled out, it will cause a paradigm shift in how we monitor and control pandemics. Success for this project depends on a multidisciplinary approach within a team that has expertise in electronics, assay development, optics, software, IVD development and a drive to get things done under strict design control and timelines. We aim at research and development at the highest international level and are building an all-star team to get it done.


We are looking for an experienced Clinical Research Project Manager with a strong background in in-vitro research studies and clinical trials. This position reports to the IVD program manager.


You will take ownership of the different in-vitro validation studies and clinical trials required to develop and validate our new sampling and analysis technology. Set-up of pilot studies and clinical trials will be done across the world, with an initial focus on Belgium and neighboring countries, followed by large scale validation studies in the USA and beyond. Throughout your work, you will interact closely with the medical, technical, and regulatory experts to define the objectives and scope of each study. This work includes experimental design, protocol writing, operational planning in hospital setting with clinicians and study nurses, submissions with clinical trial commissions and ethical committees and reporting of the results.


Your responsibilities


  • Interact with the experts to define the objectives and the scope of the different studies.

  • Interact with the hospitals and committee to define the study protocol.

  • Provide feedback and advise to the management team

  • Submit all required information, correctly and in due time to the different boards and committees

  • Plan and follow up the operational aspects of the study

  • Analyze the results and report to the stakeholders

Required knowledge and skills


  • You have experience in organizing clinical research studies and trials in Belgium/EU. USA experience is a plus

  • Experience in IVD development is a strong plus

  • Clinician network is a strong plus

  • Experience with infectious diseases is a strong plus

  • A team player with excellent communication skills and fluent in English




Reference: 972593204

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