Senior Rep, Clinical Records

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.

How you will make an impact:

• Reviewing and ensuring accuracy and completeness of clinical study documents (e.g., EFS, pivotal) ensuring GDP and performing quality checks with limited supervision.
• Organizing and archiving documents and data in eTMF (electronic trial master file) and/or CTMS (clinical trial management system) ensuring compliance with internal procedures and regulatory guidelines.
• Performing quality checks and escalating issues or remediations to management.
• Providing training and knowledge transfer to team members.
• Reviewing clinical data for completeness of study files.
• Retrieving documents in support of internal and external audits utilizing knowledge of eTMF filing structure.

What you’ll need (Required):

• H.S. Diploma with 4 years of previous related experience.

What else we look for (Preferred):

• Bachelor’s Degree
• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with TMF preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Full knowledge and understanding of Edwards policies, SOPs, domestic medical device regulatory guidelines relevant to clinical study documentation
• Good knowledge of EW GDP (Good Document Practice) SOP requirements with the ability to provide feedback to authors and approvers on deficiencies
• Strict attention to detail
• Ability to manage confidential information with discretion
• Ability to interact professionally with all team organizational levels
• Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
• 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, the base pay range for this position is $61,000 to $86,000 (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.

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.