About this role
Role Overview
- Patient screening and selection for first-in-class Transcatheter Mitral Valve Replacement (TMVR) clinical studies
- Assist in 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 summaries 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 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.
Requirements
- Bachelors’ degree in life sciences or related field
- Minimum 4 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.
- Experience working in a clinical setting and being integrally involved in delivering care directly to patients
- Experience utilizing image viewing and processing software for computed tomography (CT) and echocardiographic analysis.
- Demonstrated ability to solve problems independently by seeking input from multiple stakeholders.
- Ability to work in a team and work as individual contributor in a fast-paced, changing environment.
- Ability to engage others to accomplish projects.
- Demonstrated skill and tactfulness in working as a cross-functional team member.
- Experience in clinical research studies collaborating with cross-functional clinical research partners, physicians, and other healthcare providers.
- Well-organized and self-motivated with an ability to initiate and follow through on assignments.
Benefits
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- 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.