Manager, TMVR Screening

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Manager, TMVR Screening

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position can either be remote or work out of our St Paul, MN location, supporting Structural Heart products in Abbott’s New Ventures division.  Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

As the TMVR Screening Manager, you will lead the team performing the patient selection and screening process for Cephea clinical studies. The incumbent will work closely within the internal clinical study team including the clinical science, project management, field clinical affairs, medical affairs, biostatistics, study management, and data management, as well as with external investigative teamsto develop and execute on the Transcatheter mitral valve replacement (TMVR) screening process for clinical studies. This position will have significant interaction with executive leadership, physicians and clinical operations teams. 

What You’ll Work On

• Patient screening and selection for first-in-class Transcatheter Mitral Valve Replacement  (TMVR) clinical studies
• Developing materials to enable patient selection for TMVR studies based on complex analyses of medical imaging data, as well as other materials (reports summarizing findings, preparation of summariess etc,) to support trial enrollments
• Independently owning the screening process end-to-end from image acquisition to final decision for inclusion/exclusion by an independent subject eligibility committee (SEC)
• Interfacing and collaborating directly with physician investigators, directing, and training them to ensure that the right types of subjects are screened for the trial
• Proactively and critically examining ways to enhance overall clinical trial performance
• Providing ongoing feedback concerning all aspects of study screening experience for the purpose of developing and implementing strategies that will contribute to organizational and corporate goals and objectives
• Collaborating with the internal core clinical study team and clinical sites to share best practices and develop capabilities to optimize trial participation and contribution
• Complying with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
• Assisting with design, development, and monitoring of clinical evaluation projects
• Hiring, managing tasks, mentoring and training screening team members to increase team productivity and achieve goals

Required Qualifications

• Bachelors’ degree in life sciences or related field
• Minimum 8 years related clinical and/or medical industry work experience with in-depth knowledge of structural heart, cardiology, cardiovascular surgery, and/or critical care medicine. Strong working knowledge in heart valve replacement and repair, transcatheter structural heart technologies, echocardiography, cardiovascular hemodynamics, and heart failure medicine.
• Significant experience working in a clinical setting and being integrally involved in delive