Edwards Lifesciences Associate Analyst, Clinical Patient Screening - Transcatheter Mitral and Tricuspid Therapies - Irvine, CA in Irvine, California
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease.
The Associate Analyst, Clinical Patient Screening is responsible for the management of screening workflows for early feasibility and pivotal studies.
• Implement clinical and pre-clinical screening strategy in collaboration with team members
• Design, review and/or conduct literature searches and complete literature reviews in collaboration with team members
• Analyze routine core lab data to support abstracts and publications and screening routine data for trends and patterns to refine and improve processes
• Analyze routine data to create metric reports to communicate trial cadence and any roadblocks to EW leadership team
• Assist with weekly screening case review calls with study investigators and circulate appropriate documentation for patient eligibility status
• Enforce timely and accurate imaging submissions from clinical sites to allow for internal review by stakeholders (e.g. Screening, Clinical Development, Case Support, and Safety)
• Assist with coordinating with Clinical Trial Management to conduct site training for screening
• Other incidental duties
Education and Experience:
Bachelor's Degree in in Biological or Life-sciences field, 1 year of previous related experience Required.
Optional but Preferred:
1 year experience in medical device industry, core labs, or clinical trial management.
Knowledge of echo imaging
• Good computer skills in Microsoft Office Suite, including Word, Excel, and PowerPoint and related system(s)
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• Good knowledge and understanding of Edwards policies, procedures, and guidelines relevant to clinical studies
• Good understanding of medical terminology as it relates to clinical studies
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to work in a team environment, including immediate supervisor and other team members in the section or group
• Ability to build stable working relationships internally
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.