Associate Analyst, Clinical Operations

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 Associate Analyst, Clinical Operations, you will manage dynamic and high-volume core lab projects across all THV global clinical studies. Your role will ensure the accurate and timely transfer of images from study sites to Independent Core Labs, and the seamless transfer of clinical data from Independent Core Labs to Edwards' data management teams. This is crucial for providing unbiased study results.

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:

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

• Identify critical elements and organize data from internal and external sources and analyze clinical output of basic studies.

• Develop basic criteria of workflow timeline assessment from clinical site through Image workflow vendor to Independent Core Lab, in collaboration with clinical stakeholders.

• Communicate study trial status from Core Lab image perspective, including issues and successes to clinical stakeholders and all levels of management.

• Facilitate training sessions for site personnel and/or Edwards personnel, based on technical content provided by the Core Lab Manager.

• Other incidental duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree

• 1 year of relevant work experience, including hands-on clinical research experience

What else we look for (preferred):

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

• Demonstrated project management and operations management experience within a clinical study setting

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

• Good written and verbal communication skills and interpersonal relationship skills

• Good problem-solving and critical thinking skills

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

• Basic 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 immediate supervisor and other team members in the section or group

• Ability to build productive internal/external working relationships

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 $57,000 to $80,000 (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 web