Clinical Drug Delivery Device Lead

Il y a 2 mois


Bruselas, Belgique CK Group Temps plein
Job Title: Senior Clinical Drug Delivery Device Lead

Work Location: Braine

Country: Belgium

Duration: 6 months

Rate: €68.00 - €75.60 phr (8 hours per day) depending on experience

Your main duties as a Clinical Drug Delivery Device Lead will include:
  • Supporting in selection and/or assessment of drug delivery devices that are to be used in sponsored clinical trials.
  • Defining and implementation of the overall strategy for the various drug delivery devices to be used in the clinical trials.
  • Working with a cross-functional team (including clinical, QA, RA, safety and SME teams) to ensure timely support to clinical trials.

Additional duties will include:
  • Leading the Clinical Drug Delivery Devices sub-teams to ensure appropriate selection and assessment of drug delivery devices to be used in the clinical trials.
  • Performing the technical assessment for devices used in clinical trials and selected by our CROs.

Your Background:
  • A master s degree with a relevant academic background, ideally a nurse or a physician.
  • 8+ years of experience in a clinical drug delivery devices selection.
  • Very good knowledge of medical devices and pharmaceutical environments.
  • Experience in clinical trials set-up.
  • Understanding of the issues and challenges of selecting appropriate and fit for purpose devices from FIH to Phase 4 clinical trials studies.
  • Thorough knowledge and understanding of Medical Devices Regulations (EU MDR, 21CFR part 820, ISO13485) and in GxP (GMP and GCP).

Apply:
It is essential that applicants hold entitlement to work in Belgium. Please quote job reference 106433 in all correspondence.
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