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