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.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you will make an impact:
- Conducting in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations.
- Assessing current processes, identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas.
- Partnering with cross-functional teams (e.g., clinical data management, field teams) with query management, data reviews and resolution.
- Identifying and investigating discrepancies in study documentation by applying clinical protocol and GCP knowledge and developing processes to mitigate reoccurrence throughout study phases.
What you’ll need (Required):
- Bachelor's Degree in Life Sciences or Nursing with 3 years of experience in clinical research (site management, clinical project management, monitoring, and/or CRC) including quality assurance/control and regulatory compliance or field monitoring with experience in the healthcare industry or equivalent work experience based on Edwards criteria
- Experience in electronic data capture
What else we look for (Preferred):
- Medical device clinical trial experience
- Cardiovascular or structural heart clinical research experience
- Experience supporting audits and inspections
- Experience working as a Clinical Research Coordinator (CRC) at an investigational site
- Experience working for a Sponsor and/or CRO supporting clinical trial operations (such as a CRA or IHCRA)
- Experience supporting site management, study conduct, data review, regulatory documentation, and/or study closeout activities
- Experience working with electronic clinical systems including EDC, CTMS, and/or eTMF platforms
- Strong knowledge of ICH-GCP, FDA regulations, and clinical research best practices
- Demonstrated ability to build productive relationships with investigators, CRCs, and site personnel
- Excellent organizational skills with the ability to manage multiple sites, priorities, and deadlines simultaneously
- Strong problem-solving, critical thinking, and risk assessment skills
- Ability to independently drive issue resolution and follow-through
- Strong written, verbal, and presentation skills
- Experience reviewing and maintaining high-quality regulatory and TMF documentation.
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 $87,000 to $123,000 (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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Skills Required
- Bachelor’s degree in Life Sciences or Nursing and 3 years of clinical research experience, including site management, clinical project management, monitoring, or clinical research coordination, with quality assurance/control and regulatory compliance or field monitoring experience in healthcare
- Experience with electronic data capture
- Medical device clinical trial experience
- Cardiovascular or structural heart clinical research experience
- Experience supporting audits and inspections
- Experience as a Clinical Research Coordinator at an investigational site
- Experience supporting clinical trial operations for a sponsor or CRO, such as CRA or IHCRA experience
- Experience supporting site management, study conduct, data review, regulatory documentation, or study closeout activities
- Experience with electronic clinical systems including EDC, CTMS, or eTMF platforms
- Strong knowledge of ICH-GCP, FDA regulations, and clinical research best practices
- Ability to build productive relationships with investigators, CRCs, and site personnel
- Excellent organizational skills and ability to manage multiple sites, priorities, and deadlines
- Strong problem-solving, critical thinking, and risk assessment skills
- Ability to independently drive issue resolution and follow-through
- Strong written, verbal, and presentation skills
- Experience reviewing and maintaining high-quality regulatory and TMF documentation
Edwards Lifesciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.
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Healthcare Strength — Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
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Retirement Support — A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
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Equity Value & Accessibility — An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.
Edwards Lifesciences Insights
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
