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 impacts 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 Analyst, you will oversee the management of complex and high-volume core lab projects across all THV global clinical studies. Your role will ensure the precise and timely transfer of images from study sites to Independent Core Labs, and clinical data from Independent Core Labs to Edwards’ data management teams, ultimately delivering unbiased study results by upholding data integrity and accuracy throughout the process.

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 ability to commute onsite.

How you'll make an impact:

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

• Identify technical and data issues and collaborate with appropriate team members to bring to resolution; Assist in the determination of root cause and recommend and implement corrective actions

• Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., open information requests, aging issues, status of image analysis from Core Labs to study database, etc.)

• Develop basic timeline assessment and/or work with senior level team members on complex timeline assessment (e.g., clinical site through Image workflow vendor to Independent Core Lab) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines

• Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables

• Assist in the development of training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff

• Other duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree in related field

• 3 years of relevant work experience, including hands-on clinical research experience

What else we look for (preferred):

• Experience in vendor management, clinical trial management/execution, and study startup activities

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

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

• Experience with clinical systems and platforms, including RAVE, CLARIO, Veeva, and CTMS

• In addition to demonstrating the ability to work effectively in a team environment, candidate must also be capable of working independently and be self-sufficient

Additional skills:

• Good computer skills in usage of MS Office Suite including MS Project and excellent Excel skills required

• Excellent written and verbal communication skills and interpersonal relationship skills

• Solid understanding and knowledge of principles, theories, and concepts relevant to clinical trial management

• Solid knowledge of human anatomy and physiology

• Good problem-solving, organizational, analytical and critical thinking skills

• Strict attention to detail

• Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment

• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects

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 $72,000 to $95,000 (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.