The Manager, Clinical Education will provide medical education to clinical sites’ staff. This includes, but is not limited to, developing and implementing medical education programs to ensure the safe and high quality medical care of patients undergoing Fractyl’s Revita DMR procedure; and attending cases as assigned. The individual is a subject matter expert for all matters related to conducting medical procedures, including, but not limited to, appropriate patient selection, pre-procedure patient dietary and medication management, the Revita procedure, the operation of Revita system, and patient management during and after the procedure. To successfully deliver on assigned deliverables, s/he will interact closely and successfully with internal teams (medical affairs, clinical operations, commercial & marketing, product development teams) and site clinical staff (doctors and nurses) drawing from their hands-on experiences and incorporating the learnings as appropriate. This role requires travel to clinical sites globally, with flexibility for short-notice trips.
- Develop learning/educational program, outlining objectives and successfully implementing the program.
- Successfully implement standardized clinical educational materials for all aspects of the Revita DMR procedure that are compliant, in accordance with Fractyl’s Quality Management System requirements, labeling requirements (i.e. IFU), and clinical protocol (as applicable), and of the highest quality. This includes education materials for various audiences such as proceduralists, procedure support teams, clinical study teams, referring physicians, and patients. Topics include disease state background, setting up the hospital and endoscopy suite for a successful Revita DMR procedure, appropriate patient selection, pre-procedure patient nutrition and medication management, pre-procedure endoscopy suite set-up, attending the Revita procedure, successful operation of the Revita system, and patient nutrition and medication management during and after the procedure.
- Perform hands on clinical education. As a subject-matter expert, communicate and teach patient-management and procedure steps and proper techniques to a variety of clinical staff. This will involve education occurring in a variety of settings: virtual webcast, formal didactic presentations to sizeable groups, smaller group round table meetings and one on one meetings, and others as necessary and appropriate.
- Attend cases as a proctor, developing the knowledge and skills necessary to become a subject matter expert in endoscopy and all aspects of the Revita DMR procedure.
- Effectively convey user experiences and feedback to the appropriate internal teams.
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned.
Education or Certification Requirements
- Bachelor’s degree in a scientific or related discipline (BS, RN)
- Medical training preferred.
- Prior experience working in operating rooms preferred.
Professional Work Experience
- 8+ years working in a clinical/medical environment
- Direct experience with education and training program design and implementation
- Successful experience proctoring a medical device procedure
- Experience working with endoscopic procedures and devices preferred
- Team management experience preferred
- Experience working on active clinical studies
- Excellent knowledge of Good Clinical Practices (GCP)
- Demonstrated success developing a clinical education program
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Qualifications and Skills
- Exceptional communication skills and a working vocabulary appropriate for the clinical setting.
- Good documentation practices for training record keeping.
- Working knowledge of clinical study conduct, inclusive of successful track record of timely cross-functional communication and technical writing skills.
- Ability to stand/attend procedures for prolonged periods.
- Full understanding of GCP and other relevant regulatory knowledge.
Other Essentials and Key Success Factors:
- Successful track record of working in high-growth and dynamic organizations
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
- Highest levels of professionalism, confidence, personal values and ethical standards
- Will be required to travel up to 50% globally.