Job Description

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.

This position is based at our corporate headquarters in Irvine, California.

How you will make an impact:

• Performing study start-up and conducting activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities.
• Identifying and investigating discrepancies in study documentation by applying clinical protocol and GCP knowledge and developing processes to mitigate reoccurrence throughout study phases.
• Conducting in-house and site (if applicable) reviews of associated documentation and participating 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 team (e.g., clinical data management, field teams) with query management, data reviews and resolution.

What you’ll need (Required):

• Bachelor’s Degree or equivalent 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 experience in the healthcare industry or equivalent work experience based on Edwards criteria.
  

What else we look for (Preferred):

• Experience working in a medical device or regulated industry
• Experience in electronic data capture
• Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file), EDC
• Demonstrated experience in data analytics and visualization (Excel, PowerBI, Python, etc.)
• Strong written and verbal communication skills, presentation skills, interpersonal relationship skills, and analytical skills
• Strong problem-solving and critical thinking skills
• Understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• Knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
• Understanding of regulatory submissions, reporting, and audits
• Ability to manage confidential information with discretion
• 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 inter-departmental teams and representing the organization on specific projects
• 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 $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.

E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.