Clinical Core Labs Analyst

2 weeks ago


Irvine, United States Edwards Lifesciences Full time

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 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 for our THV Core Labs team, you will be responsible for providing project management of dynamic and high-volume core lab projects across all THV global clinical studies to ensure accurate and timely transfer of images from study sites to Independent Core Labs, and clinical data from Independent Core Labs to Edwards' data management teams to ultimately provide un-biased study results.

**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 incidental duties assigned by Leadership

**What you'll need (required)**:
Bachelor's Degree in related field AND 3 years of previous hands-on clinical research experience

**What else we look for (preferred)**:
Project management/operations management experience in the clinical study setting
Experience working with clinical data
Advanced Microsoft Excel skills including pivot tables, VLOOKUPS, conditional formatting, importing data, creating graphs/charts, etc.
Vendor selection and management experience
Experience from a sponsor

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 $70,000 to $100,000 (highly experienced).



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