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4C Medical Technologies, Inc. · 3 months ago

Clinical Development Senior Specialist - Imaging (US Remote)

United States

Full-time

Remote

Senior Level

5+ years exp

4C Medical Technologies, Inc. is a pioneering company focused on innovative therapies for transcatheter mitral valve replacement. The Clinical Development Senior Specialist will lead imaging optimization and physician education for TMVR procedures, ensuring high standards of imaging quality and providing expert support during live procedures.

Health CareMedicalMedical Device

Responsibilities

Create and update standardized imaging protocols for procedures, ensuring consistency and quality across all stages

Train and provide hands-on education to clinical teams, including physicians and sonographers, on using echo imaging for device deployment

Offer expert guidance and technical support during live procedures to ensure optimal device positioning and to troubleshoot any imaging challenges

Conduct post-procedure reviews, analyze data trends, and ensure adherence to imaging protocols to maintain high standards

Act as the key point of contact for imaging, providing expertise for device development, regulatory submissions, and clinical publications

Ensure imaging data quality and compliance with regulatory requirements for clinical trials

Evaluate site capabilities, recommend equipment or training, and support patient screening through comprehensive imaging reviews

Develop and update imaging-focused training materials and competency assessments

Integrate clinical imaging feedback directly into new device development and procedural improvements

Solve complex imaging issues and recommend innovative solutions to overcome procedural barriers

Qualification

Cardiac Imaging ExperienceEchocardiography ExpertiseTranscatheter Mitral Valve ProceduresRegistered Diagnostic Cardiac SonographerRegulatory ComplianceData AnalysisTechnical TrainingProfessionalismProblem-SolvingCommunication Skills

Required

Associate's degree in cardiovascular technology, diagnostic medical sonography, or related clinical field

5+ years of cardiac imaging experience, with at least 2 years in structural heart interventions

Extensive experience with transesophageal echocardiography in interventional settings

Demonstrated expertise in transcatheter mitral valve procedures or similar structural heart interventions

Registered Diagnostic Cardiac Sonographer (RDCS) certification required

Ability to travel extensively, both domestic and international

You have a deep understanding of advanced echocardiographic principles, including 3D and fusion imaging, along with mastery of image optimization techniques

You're a subject matter expert in transcatheter mitral valve replacement (TMVR) and other structural heart procedures, including device-tissue interactions and identifying complications

You're skilled in providing imaging-guided support during device positioning and deployment in high-pressure environments

You understand and apply FDA guidelines, Good Clinical Practice (GCP), and imaging core lab standards to ensure compliance

You have a proven ability to educate and train clinical teams on complex imaging concepts, developing comprehensive educational materials and competency assessments

You're proficient with imaging analysis software and data management systems, capable of analyzing complex imaging data

You can effectively manage and coordinate imaging activities across multiple clinical sites

You excel at troubleshooting and providing solutions for complex imaging challenges

You have strong interpersonal and presentation skills, enabling you to effectively communicate with both technical and clinical audiences

You demonstrate exceptional organizational skills, attention to detail, and the ability to maintain composure under pressure