Echocardiography Program Manager
6 days ago
Houston
Job DescriptionDescription: This is a hybrid position. COMPANY & COMPENSATION: • Medical Metrics Inc. (MMI) is a fast-growing, independent imaging core laboratory based in Houston, TX. MMI provides image analysis and consulting services to medical device, biologics, and pharmaceutical companies in support of their clinical trials and product R&D., • Competitive salary, commensurate with experience and qualifications, • Excellent benefits package including medical, dental, and life insurance, 401(k) plan, and paid vacation and holidays JOB SUMMARY: The Echocardiography Program Manager utilizes their clinical imaging and research expertise to provide strategic and tactical support to grow MMI’s echocardiography program. This includes protocol development, software evaluation, deployment, and enhancements, project configuration, site training, image quality evaluation, training of physician reviewers and echocardiographers, technical analysis, quality control, and other functions requiring specialized knowledge of echocardiography. The position requires independent performance of tasks as well as collaboration with a diverse team including engineers, analysts, imaging technologists, physicians, project managers, business development staff, clients, partners, and regulatory authorities. This role may also entail supervision of sonographers or other staff necessary to operate MMI’s echocardiography program. DUTIES AND RESPONSIBILITIES: • Design business processes, templates, and tools for the implementation of the echocardiography program, • Develop project-specific training materials and conduct training for internal analysts, imaging technologists, and physician reviewers, • Perform technical analysis of imaging prior to physician review and certification, • Advise internal staff on echocardiography (e.g., TTE, TEE, 3D, Stress Echo, etc.) image collection techniques, analysis methods, and measurement protocols relevant to the trial based on the study treatment, academic publications, and imaging society guidelines, • Review and provide feedback on Image Review Charters, Image Acquisition Protocols, and proposals for echocardiography studies, • Liaise with Subject Matter Experts (SMEs) such as physician consultants, regulatory experts, software vendors to resolve technical and operational questions, • Establish criteria to evaluate image quality and detect potential inaccuracies in echocardiography measurements and findings, • Review trial imaging for labeling and quality; document discrepancies and nonconformance to the image acquisition protocol as feedback to the site personnel who collected the imaging, • Develop study-specific site training materials and train sites on image acquisition protocol, • Support clinical trial sites in resolving echo-related imaging discrepancies promptly, • Implement image analysis QC/QA processes for the assessments performed by physician reviewers, • Build and implement analysis templates; assist with proprietary software configurations for clinical trial databases, • Support business development activities and capabilities calls by serving as the echocardiography SME, • Assist with evaluation, recommendation, and validation of echo analysis software platforms, • Assist with client communication and technical content preparation for echocardiography topics, • Manage communication and documentation, including but not limited to meeting schedules, calendar invites, email follow-up, and technical reports, • Supervise sonographers or other internal staff and consultants, as applicable, • Provide strategic input to the executive leadership team on approaches to expand the footprint of the echo program, • Understand Medical Metrics Quality Policy and support the achievement of the organization’s quality objectives and take corrective action when necessary to mitigate organizational risk, • Comply with company policies and procedures, as well as ISO 9001 and Current Good Clinical Practices (cGCP’s) relative to job tasks, • Ensure compliance with HR policies and procedures Requirements: EDUCATION AND EXPERIENCE: • Bachelors and/or associates degree from a reputable institution, preferably in a healthcare-affiliated field, • Registered Cardiac Sonographer (RCS) credentialed by Cardiovascular Credentialing International (CCI) or American Registry for Diagnostic Medical Sonography (ARDMS) or equivalent licensure, certification, or registration, • Minimum of seven (7) years of clinical experience as a sonographer within the specialized imaging discipline, preferably working with multiple vendor/OEM systems such as Philips, GE, Siemens, etc., • Prior clinical research experience within an academic and/or industry setting, • Experienced and proficient with acquiring echocardiography imaging, • Extensive clinical knowledge of cardiac pathologies, treatments, and imaging assessments, • Familiarity with multiple image acquisition and analysis systems for echocardiography, • Exceptional communication, presentation, and client service skills, • Familiarity with relevant scientific literature and imaging society guidelines, • Excellent written and interpersonal skills, • Impeccable work ethic and attention to detail, • Solid analytical and practical problem-solving skills, • Able to plan and execute responsibilities with minimal supervision, • Effective time management, organizational, and leadership skills, • Adept at acquiring technical knowledge through personal research and self-directed study, • Experience or demonstrated interest in medical devices or biopharmaceuticals, • Understanding of clinical trials, including US-FDA 510(k) / PMA / IND regulatory pathways