Senior Clinical Development Specialist

A cutting-edge medical device company is looking to hire Clinical Development Senior Specialist, fully remote, to travel to hospitals and train/lead the use of their heart valve device. This person will report to the VP of Therapy Development and lead case preparation and proctors implanting physicians on the procedures and procedural imaging of the device. We are looking for candidates that live in the Midwest or Western part of the country.

ROLE RESPONSIBILITIES:

• Provide clinical and technical training and education for Interventional Cardiologists, Cardiothoracic Surgeons, Cardiac Cath Lab and Cardiac Surgery staff, and other ancillary personnel on the use of structural heart products.
• Partner with R&D, Clinical Operations and other internal teams to prepare for procedures
• Organizing patient specific slide presentations and leading internal reviews
• Performing “bench” deployments in 3D printed anatomies
• Identifying strategies for optimal deployments in each patient
• Proctor implanting physicians on their device and device specific echo intraprocedural imaging.
• Lead case reviews after each implant and disseminate learnings.
• Follow-up with sites to understand how patients are being managed post implant and identify any potential issues.
• Partner with R&D and other internal teams to continuously refine the implant procedure and training slides decks as needed.
• Assist with training and recruitment tools development that would aid study recruitment and help further engaged existing or new clinical sites.
• Assist with potential candidates identification (e.g., by reviewing medical history, echo, CT, etc.) and providing timely feedback to the internal management as well as clinical sites.
• Assist in identifying trends in recruitment challenges and promptly provide creative solutions for their elimination (or minimization).
• Proactively and critically examine ways to enhance overall clinical trial performance regionally and nationally.

Must Haves:

• Bachelor’s degree (preferred) in biology, physical sciences, nursing or other related field.
• Registered Diagnostic Cardiac Sonographer (RDCS) or similar credential preferred
• 3+ years of experience in the medical device industry
• Experience with transcatheter mitral repair or replacement procedures or LAA closure
• Experience with cardiac and vascular anatomy, physiology, and pathology
• Experience teaching and educating medical personnel, peers and technical support personnel
• Imaging interpretation experience (TTE or TEE, CT, angiograms)
• Strong knowledge of cardiovascular anatomy, including proficiency in structural heart field, percutaneous/endovascular devices and techniques, current interventional practices and procedures, etc.
• Thorough working knowledge of mitral terminology, mitral procedures and the medical device industry experience communicating product’s instructions for use to physicians and hospital administration
• Knowledge of FDA guidelines and regulations governing conduct of clinical trials
• Ability to travel 70% of the time

Base Salary of $155,000 to 185,000 Annually + Benefits

• Seniority level
  
  Mid-Senior level

• Employment type
  
  Full-time

• Job function
  
  Business Development, Research, and Training
• Industries Medical Equipment Manufacturing

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Medical insurance

Vision insurance

401(k)

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