Edwards Lifesciences Associate Manager, Clinical Strategy - Transcatheter Heart Valve (US Remote Position) in Los Angeles, California
Edwards is the global leader in transcatheter heart valve replacement technologies designed for the non-surgical replacement of heart valves. Delivered via catheter while the heart is beating, these valves can enable patients to experience a better quality of life sooner than patients receiving traditional surgical therapies. Launched commercially in Europe in 2007, and in the United States in 2011, our transcatheter aortic heart valves are now available in more than 70 countries and are the most widely used transcatheter heart valves in the world.
The Associate Manager, Clinical Strategy role will develop accurate and effective clinical protocols and associated study registration to align with strategic initiatives.
Essential Job Functions & Responsibilities :
Lead in the development of clinical protocols and associated documentation with accountability for successful completion within scope of project deliverables; manage the process to obtain, evaluate and incorporating input resolve from cross-functional reviewers input for document finalization
Lead in the identification and evaluation of competitive research programs to understand clinical strategies
Determine content (e.g., endpoints, eligibility) and timing of EW THV clinical trial postings in public databases, obtaining input from key stakeholders
Research and evaluate literature and other data sources to compile applicable clinical inputs for the development of clinical study designs/synopses
Other incidental duties
Minimum Education & Qualifications :
Bachelor's Degree with 8 years of relevant clinical experience; OR Master’s Degree with 6 years of relevant clinical experience; OR PhD with 4 years of relevant clinical experience
Experience in clinical trial management, monitoring and/or site management
Preferred Qualifications :
Experience writing clinical protocols
Medical Device industry experience
Experience in cardiology or interventional cardiology therapeutic areas
Knowledge of FDA and EU MDR regulations
Additional Talents & Expectations :
General knowledge of statistics
Proven successful clinical project management skills
Proven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote)
Advanced editing and proofreading skills
Strong problem-solving and critical thinking skills
Excellent written and verbal communication skills including negotiating and relationship management skills
Ability to read, write, and speak English fluently
Extensive knowledge of relevant US and EU regulations and guidelines, Good Clinical Practice requirements and other applicable standards
Extensive knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)
Ability to travel up to 10% of the time to scientific meetings/conferences and/or to our Irvine, CA corporate office
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 15,000 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.
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