Imagine how your ideas and expertise can change a patient’s 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 team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. 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.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact by:

The Clinical Safety Officer - Transcatheter Heart Valve will assure adverse events are reviewed and handled in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with Edwards Lifesciences procedures and ethical standards to ensure patient safety in clinical trials.

• Analyze medical records received from enrolling sites to identify AEs (Adverse Events), SAEs (Serious Adverse Events) or UADEs (Unanticipated Adverse Device Effects) to confirm protocol definition and propose recommendations to site.

• Develop and write complex medical narratives from multiple sources of adverse event reporting and/or complaint review forms in order to facilitate safety officers and CEC review in accordance to regulatory requirements, trial safety processes, and EW procedures.

• Provide oversight on all safety processes from the site to the CEC to ensure process flow is managed efficiently and effectively.

• Educate and provide training to enrolling sites to ensure protocol requirements are followed.

• Develop training programs and metrics for safety team knowledge in collaboration with management to optimize application of knowledge and performance.

What you'll need (Required):

• Bachelor's Degree or equivalent in biological or Lifesciences field or Nursing degree

• 5 years’ experience previous hands-on clinical research related.

• Experience with an ERP software, CTMS (Clinical Trial Management System) and Patient Tracking system -OR-

• Master's Degree or equivalent in Related field

What else we look for (Preferred):

• Medical Device Industry

• BSN degree or MSN degree

• Strong cardiovascular experience (preferably in TAVR)

• Clinical Trials experience

• International and domestic medical device regulatory guidelines relevant to clinical studies.

• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata)

• Experience with an ERP software (e.g JDE), CTMS (Clinical Trial Management System) and Patient Tracking system.

• Substantial understanding of medical terminology as it relates to clinical safety.

• Excellent written and verbal communication skills and interpersonal relationship skills

• Demonstrated problem-solving and critical thinking skills.

• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.

• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.

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, the base pay range for this position is $103,000 to $146,000 (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.