Senior Manager, Clinical Patient Screening

Imagine how your ideas and expertise can change a patients life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients lives. As part of our Clinical Affairs teamyoullhone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in close partnership with principal investigators dedicated medical professionals patient advocacy groups and regulatory authorities you will drive the evidence needed to optimize patient outcomes.

Innovation starts from the heart. Our AdvancedInnovation &Technology (AI&T) teams harness the imagination courage and resourcefulness to think beyondwhatscurrently possible and create solutions for patients many years into the future. Ifyourean early-stage innovator thenEdwardsAI&T team is the place for you to take the next steps in your you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

How youll make an impact:

• Serve as the functional lead for imaging-based patient screening ensuring high quality patient selection aligned with protocol procedural feasibility and clinical objectives.
• Lead imaging and procedure development activities supporting preclinical and clinical programs ensuring imaging and procedural strategies are clinically executable and aligned with device intent.
• Execute and oversee screening workflows in collaboration with site managers principal investigators internal imaging/CT screeners/echocardiography.
• Provide subject matter expertise during bench cadaveric and clinical activities to guide imaging use procedural flow and technical decision making
• Develop screening and imaging related plans metrics and updates and communicate risks trends and recommendations to project teams and leadership
• Partner with R&D and imaging technology vendors to influence device design imaging workflows and procedure optimization across the product lifecycle.
• Monitor screening performance metrics adjudicate complex eligibility questions and drive continuous improvement in screening efficiency and enrollment quality
• Collaborate closely with Clinical Affairs Regulatory Affairs Quality R&D and other stakeholders to support clinical execution regulatory readiness and program milestones.
  

What youll need (Required):

• Bachelors Degree in Engineer or Scientific related (Biology Lifesciences) with 8 years previous related experience working in Medical Device/Structural Heart Disease or Healthcare Industry Required
• This position will be in office sitting on site at our Irvine California Campus. Relocation is available from within USA.

What else we look for (Preferred):

• Masters Degree or equivalent 6 years related experience working in Medical Device/Structural Heart Disease or Healthcare Industry Preferred
• Ph.D. or equivalent in or Equivalent Engineering or Scientific field 4 years years experience Preferred
• Other: Certifications within ARRT CT ARDMS Adult Echo ACS Registered Professional Nurse Nurse Practitioner or Physicians Assistant Certifications Preferred
• Solid working knowledge of Good Clinical Practice (GCP) and clinical research requirements as they apply to imaging review patient screening decisions and documentation
• Clear and effective communicator able to explain imaging based decisions and recommendations to clinical technical and cross functional stakeholders
• Ability to independently interpret complex imaging datasets and translate findings into clear patient eligibility recommendations
• Experience executing imaging based patient screening workflows including collaboration with site teams investigators and internal screening resources
• Strong analytical skills applied to identifying trends variability and improvement opportunities in imaging and screening data
• Hands on experience with advanced cardiovascular imaging with strong emphasis on cardiac CT for patient screening anatomical assessment and procedural planning
• Proficiency using advanced imaging and analysis software such as 3mensio TomTec Vitrea Circle CVI or equivalent platforms
• High attention to detail with consistent focus on data quality documentation accuracy and audit readiness
• Experience providing hands on imaging and procedural guidance during bench cadaveric or early clinical studies
• Prior involvement in protocol development CRF inputs or clinical documentation related to imaging and patient screening
• Familiarity with tracking and improving screening performance metrics (e.g. turnaround time acceptance rates exclusion drivers
• Comfort operating with increasing scientific judgment and autonomy within defined program scope
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
• Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
  

Aligning our overall business objectives with performance we offer competitive salaries performance-based incentives and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA) the base pay range for this position is $145000 to $205000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g. qualifications education prior experience).Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been vaccinated for COVID-19 unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.