Associate Analyst, Clinical Device Management

Edwards Lifesciences • Irvine, CA

5d • $59,000 - $83,000

About The Position

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.

Requirements

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

Nice To Haves

• 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

Responsibilities

• 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).

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level