Associate Analyst, Clinical Device Management

Imagine how your ideas and expertise can change a patients 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 youll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients 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 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 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:

• Communicating regularly with sites to resolve basic queries.
• Investigating and analyzing discrepancies between site and JDE data on device accountability in collaboration with stakeholders (e.g. Finance Customer Service).
• Providing training on device accountability process within electronic database (e.g. SalesForce) for cross functional team members (e.g. clinical specialist and field monitors).
• Identifying developing recommending and implementing basic process development and process improvement solutions to trial workflow timelines (e.g. device accountability data).
• Partnering with Quality to resolve device related issues.
• Compiling and analyzing accurate date of regulatory reports for submission for the regulatory bodies (e.g. FDA).

What youll need (Required):

• Bachelors Degree or equivalent in related field with 1 year of previous clinical trial management experience or equivalent work experience based on Edwards criteria.
  

What else we look for (Preferred):

• Good computer skills in usage of MS Office Suite including Excel JDE electronic database (e.g. Salesforce)
• Good written and verbal communication skills and interpersonal relationship skills
• Good understanding and knowledge of fundamental principles theories and concepts relevant to clinical trial management
• Good understanding and knowledge of clinical device accountability
• Good problem-solving organizational analytical and critical thinking skills
• Ability to manage confidential information with discretion
• Good knowledge of regulatory requirements (e.g. CFR GCP) and documents
• 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 (CA) the base pay range for this position is $59000 - $83000 (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.