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.
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. 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 files.
- Organizing documents and data in ETMF (electronic trial master file), CTMS (clinical trial management system) and ensuring compliance with internal procedures. Reviewing clinical data for completeness for multiple clinical research trials.
- Collating new study materials, creating study binders, patient recruitment materials, and arranging shipment of materials to clinical sites.
What you’ll need (Required):
- H.S. Diploma with previous work 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 an ERP software, JDE and CTMS (Clinical Trial Management System)
- Good written and verbal communication skills and interpersonal relationship skills
- Ability to work in a fast-paced environment
- Knowledge and understanding of Edwards policies and SOP, and domestic medical device regulatory guidelines relevant to clinical study documentation
- Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
- Good written and verbal communications skills
- Good problem-solving skills
- Ability to manage confidential information with discretion
- Strict attention to detail
- Ability to interact professionally with all organizational levels
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 $53,000 to $75,000 (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.