Consultant, Clinical Project Lead, Medical Devices

Company: GForce Life Sciences
Location: Hackensack
Posted on: November 24, 2019

Job Description:

Summary: Our client, a global medical device manufacturer, has engaged GForce Life Sciences to identify a Clinical Project Lead who will be responsible for various aspects of assigned clinical studies, from protocol drafting through study summary and final report. Duties / Expectations:

• Draft clinical study protocols and prepare all technical reports, abstracts, and presentations required for assigned studies
• Upon completion of an assigned study, compile a final report and summary of study results
• Interpret and present study findings to colleagues, including members of the leadership team
• Review relevant medical & scientific literature, study results, and data to stay up-to-date with trends in laboratory medicine
• Identify necessary testing to address clinical risks for product changes
• Provide consultation, from a clinical standpoint, for HEOR studies, HFE studies, and post market studies
• Ensure safety, efficacy, and clinical utility of the assigned product
  Mandatory Requirements:
  • Bachelor of Science in Biology, Biochemistry, or related field
  • 1-3 years of clinical laboratory or clinical research experience is required, with medical device experience being highly preferred
  • Must have experience drafting clinical study protocols
  • Demonstrated knowledge of technical writing and clinical study design
  • Knowledge of laboratory workflow related to blood collection and handling
    Nice to Have Requirements:
    • Advanced degree in a health-related field
    • MT (ASCP) or equivalent is desirable
    • Project management experience
    • Previous experience working on clinical trials
    • IVD experience is a plus
      Term & Start:
      
      • Start ASAP
      • 12 + month contract
      • Must be in Northeastern New Jersey or willing to relocate.

Keywords: GForce Life Sciences, Hackensack , Consultant, Clinical Project Lead, Medical Devices, Professions , Hackensack, New Jersey