Latest career opportunities with SurgVision

Clinical Development Manager ref: SVC001

Location:

Essential Job Functions:

‘t Harde, The Netherlands

  • Proactively drive and develop the set up of upcoming clinical studies.
    Generate all necessary documentation to obtain approval to start clinical trials in the EU and USA.
  • Interact with official authorities, e.g. FDA, BfArM, NHS etc. to support effective completion of registration
  • Develop a process for improvement of Clinical Study standard operating procedures (SOPs) and templates.
  • Develop internal processes for complaint handling with regard to clinical trials.

A high-tech innovative start-up company active in equipment development of devices and tracers in the medical and pharmaceutical industry. Activities range from concept creation, product and process development, to prototyping and (small series) production and eventually industrialization.

Experience:

  • Minimum of 3 years experience through a clinical research organization or Medical Device / Pharmaceutical industry.
  • Experience with the design of clinical trials and clinical end-points.
    A demonstrated working knowledge of GCP, ICH guidelines, FDA regulations as well as EU regulations.
  • Experience with execution of clinical trials.
  • Experience with EDC and Data Management.
  • Preferably medical education, or education in medical related science (Master)
  • Strong organizational abilities.
  • Proficient computer skills across multiple applications with experience in and an aptitude for clinical trial software.
  • Excellent English oral and written communication skills