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.

Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

As the Associate Analyst, Clinical Operations, you will play a pivotal role in ensuring clinical operations deliverables and analytics are completed. The position will be on-site located at our Irvine headquarters. Candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute onsite.

How you'll make an impact:

Study device management including ordering, accountability and returns

Identify, develop, recommend, and implement basic process development and process improvement solutions to optimize global trial workflow timelines, (e.g., device return aging issues, status of open device issues/queries, etc.) including analyzing clinical device data

Using approved templates, draft, redline and negotiate contracts, including NDAs, letters of termination, clinical trial agreements, service agreements, statements of work, amendments, etc.

Negotiate clinical contract budgets

Work collaboratively with various departments in order to process contract related requests, including Edwards’ Legal and Compliance departments, Risk Management, study managers, field staff, and clinical group directors

Review and ensure accuracy and completeness of clinical study documents ensuring GDP and performing quality checks with limited supervision with limited direction.

Organize and archive documents and data in eTMF (electronic trial master file) and/or CTMS (clinical trial management system) ensuring compliance with internal procedures and regulatory guidelines. 

Assist with internal audits to ensure audit readiness at all times

Other duties as assigned (e.g. audit support)

What you'll need (Required):

Bachelor's Degree

1 year of relevant work experience that includes hands-on clinical operations experience

What else we look for (preferred):

Proficient in using the MS Office Suite, including Excel

Excellent written and verbal communication skills, along with strong interpersonal relationship abilities

Good understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management

Good problem-solving, organizational, analytical and critical thinking skills
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 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 $57,000 to $80,000 (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.