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Our small start-up client recently received FDA approval to start an early feasibility trial and are adding a Field Clinical Manager or Director to the team. The FCS will report to the VP Clinical, Regulatory, and Operations. This will be the first FCS for their second generation product. This position will manage the clinical engineering team and all field activities related to the organization’s sponsored clinical research programs.  Primary responsibilities will include the recruitment, development and management of the Field Clinical Engineering (FCE) staff to meet departmental and corporate objectives. This position will be a key contact in the development of relationships with influential key opinion leaders and centers of excellence worldwide.  Additionally, this position will provide technical product direction and consultation to physicians in an interventional cath lab or hybrid suite setting. Your role with the company:
  • Manage relationships with clinical sites related to companies ongoing clinical trials.
  • Work closely with VP of CL/RA/Operations to assure integration of departmental objectives with organizational objectives.
  • Responsible for the recruiting, hiring, training, developing and management of companies FCE team.
  • Implement and oversee the education and training of clinical personnel (physicians and nurses) on protocols, clinical processes, and the application of companies device.
  • Implement and oversee appropriate technical support, including device preparation, patient selection and case proctoring, for clinical procedures in an interventional cath lab or hybrid suite setting. These procedures might include both implants and follow-up visits.  Troubleshooting of difficult cases will be required.
  • Serve as liaison between physicians and the company regarding clinical research issues, including field research, feasibility studies, CE & IDE clinical trials, troubleshooting and future product features, etc.
 Desired Profile:
  • B.S. or graduate degree in the health/life sciences, or engineering.
  • 15+ years clinical research experience including a demonstrated track record of people leadership experience for the last 3+ years.
  • Significant direct cardiovascular case proctoring experience in an interventional cath lab or hybrid suite setting is required.
  • Complete understanding of the wide application of technical principles, theories, therapies, and concepts in the cardiovascular field.  
  • Thorough understanding of in-house/field study management and its dynamics/interactions.
  • Experience with implantable cardiology related products and technologies.
  • Experience managing pre-market device studies during feasibly and pivotal IDE phase.
 
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