Field Procedural Specialist

Orchestra Bio Med (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies. Its partnership-enabled model is designed to drive successful global commercialization of the products it develops in collaboration with these industry leaders. Orchestra Bio Med’s lead product candidate is Atrioventricular Interval Modulation (AVIM) Therapy for the treatment of hypertension, the leading risk factor for death worldwide.

Orchestra Bio Med is also developing the highly differentiated Virtue® Sirolimus Angio Infusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra Bio Med has strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic agreement with Terumo, a global leader in medical technology for development and commercialization of Virtue SAB for the treatment of artery disease.

For further information about Orchestra Bio Med, please visit  and follow us on Linked In.

Field Procedural Specialist supports and manages critical trial activities in the field as needed. This individual will be actively involved in identifying potential study centers and building relationships with existing centers, encouraging them to recruit and enroll patients in our study. This person will provide direct technical support to the centers during surgical procedures. Currently, this will include the studies in our Virtue program but may expand as future studies as appropriate.

This key role will be remote and will have significant travel.

• Partner with study center colleagues to recruit and enroll patients.
• Provide Direct technical support during interventional cardiology procedures where applicable.
• Plan, coordinate and complete each project on schedule.
• Operate and maintain study related equipment in accordance with establish policies and procedures.
• Assist in completion of documentation in case record forms during clinical trials, as needed.
• Keeps track and support site performance in terms of patient recruitment and timely response to the company's requests.
• Maintains documentation regarding any product-related issues.
• Trains medical staff on device related equipment and serves as the first point of contact for any technical questions from the medical team.
• Road Warrior level travel required (Up to 80%).

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of an employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Actual Title, FCE, Sr FCE, Principal FCE will be determined based on experience.

• Bachelor’s degree nursing or other relevant scientific discipline strongly preferred.
• 3+ years of related experience and/or training working in Interventional Cardiac Cath Labs; or equivalent combination of education and experience required.
• Experience and/or knowledge of the management of clinical research processes for interventional medical device trials with 3+ years of experience in cardiology trials strongly preferred.
• Experience providing expert level consultation and training to Internal and External colleagues.
• Strong imaging experience is required.
  
  Specifically in the cardiac arena
• Basic physiological knowledge is desirable.
• Demonstrated ability to work well in a collaborative and dynamic team environment, set priorities, and drive results.
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.
• Demonstrated superior oral and written communication skills and ability to communicate complex issues in a succinct and logical manner.
• In-depth knowledge of Good Clinical Practice (GCP) and…