Summary of Role

We are seeking a clinical director to join our growing medical technology company.

This individual will be responsible for:

  • Leading Clinical team and represent Clinical function on Element Science Executive Team
  • Developing clinical operations strategy to conduct multi-center IDE trial
  • Building clinical team to support US IDE trial
  • Be Element Science executive liaison to clinical sites, KOLs and Principal Investigators
  • Managing clinical protocols to enable clinical evaluations of our technology
  • Managing study timelines of multi-center trials
  • Performing clinical site evaluation to assess site suitability
  • Clinical site onboarding and initiation to use our technology
  • Clinical site staff training on study design, requirements, and device use
  • Ensuring site compliance with protocol, including patient identification and follow-up
  • Managing clinical site data collection and site monitoring
  • Collaborating to interpret and describe data generated from the clinical work
  • Communicating clinical results to R&D team

Deliverables

  • All aspects of clinical protocols (CIP, CRF, ICF)
  • Identification/activation of appropriate clinical sites, negotiation of site agreements
  • Day-to-day management of Element Science Clinical team
  • Execution of clinical study management according to GCP Guidelines
  • Management of data collection and monitoring per study plan
  • Preparation of clinical study reports

Qualifications

  • Experience conducting US medical device clinical trials preferably with IDE experience (10+ years experience)
  • Science or Engineering background required (M.S. or B.S)
  • Evidence of data analysis and presentation of clinical data to engineers and scientists
  • Appreciation for quality system, risk management, and medical product development processes
  • Cardiology experience preferred but not necessary
 
Interested? Send a short introduction and your resume to jobs@elementsci.com