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 and aortic regurgitation impact millions of people globally, yet it often remains under-diagnosed and under-treated. 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.

As the Clinical Operations Manager (Clinical Imaging), you will lead a team of in-house clinical research professionals, overseeing all clinical trial related Clinical Imaging and Core Lab management activities. Establish and maintain sites with comprehensive training resources, effective communication channels, and robust data security measures to ensure the success of clinical studies. The position will be on-site located at our Irvine headquarters. Candidate must reside within a reasonable distance from the Irvine Corporate location and have the ability to commute onsite.

How you'll make an impact:

• Manage and oversee the work of a clinical operations team and contractors/vendors, as appropriate. Develop team members to increase business acumen and functional skills. Collect performance feedback of assigned staff from cross-functional stakeholders. Assign and prioritize work-related assignments to direct reports.

• Plan core labs study start-up activities (e.g., contracts, scope of work, training, case report form development) with accountability for successful completion within scope of project deliverables.

• Provide strategic direction on field and remote monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial documentation is within parameters of study protocol, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.

• Identify and evaluate alignment opportunities to standardize processes across the organization and lead the implementation of course correction.

• Analyze clinical output of highly complex studies and provide high level summary with supporting details of study trial status (e.g., Core Lab image perspective) with significant complexity to stakeholders and clinical management.

• Develop materials in collaboration with Core Labs and lead the execution of site training (e.g., image acquisition protocols) for clinical stakeholders.

• Other incidental duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree in related field

• 8 years of experience in clinical trial operations, clinical research management, or clinical project management, specializing in cardiovascular disease

• Ability to work on-site 4 days/week

• Ability to travel up to 10%

• Covid vaccination

What else we look for (preferred):

• 1-2 years of leadership or people management experience, with a demonstrated ability to mentor and guide junior talent

• Proficient in Microsoft Office Suite, related tools and clinical systems (e.g., RAVE, CLARIO, Veeva, CTMS)

• Expertise managing critical aspects of clinical trials involving advanced imaging modalities, including CTs, Echocardiograms, Fluoroscopy, and MRIs

• Demonstrated project management and operations management experience within a clinical study setting, showcasing the ability to effectively oversee and coordinate aspects of complex clinical trials

• Proficiency in Microsoft Excel, including VLOOKUP, pivot tables, conditional formatting, and importing data, etc.

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 $118,000 to $150,000 (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.