Associate Analyst, Clinical Device Management

Clinical Affairs Team Member

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.

This is an onsite position in Irvine, CA. Selected candidate must reside within a reasonable distance from the Irvine corporate location and have the ability to commute on required onsite days.

How you'll make an impact:

• Communicating regularly with sites and field team 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, Clinical IT).
• Providing training on device accountability process within electronic database (e.g., SalesForce) for cross functional team members (e.g., clinical specialist and field monitors) and site personnel.
• 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).
• Other incidental duties.

What you'll need (Required):

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

What else we look for (Preferred):

• Experience with an ERP software (i.e., JD Edwards), Salesforce and CTMS (Clinical Trial Management System)
• Strict attention to detail
• Strong problem-solving, organizational, analytical and critical thinking skills
• Strong written and verbal communication skills
• Strong interpersonal relationship skills
• Good computer skills in usage of MS Office Suite
• Good understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management
• Good understanding and knowledge of investigational device accountability
• Good knowledge of regulatory requirements and documents (e.g., Code of Federal Regulations, Good Clinical Practices, Good Documentation Practices)
• Good understanding and knowledge of clinical trial master files (TMFs)
• Ability to manage confidential information with discretion
• Ability to interact professionally with all organizational levels and site personnel
• Must be able to work in a team environment, including immediate supervisor and other team members
• Ability to build productive internal/external working relationships
• Ability to partner with stakeholders to manage inventory and device accountability for sites
• Ability to ensure clinical sites are sufficiently set up and stocked with trial supplies and track their lifecycle in related system/tool under general supervision
• Ability to 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
• Ability to retrieve, review, and ensure GDP accuracy and completeness of clinical study documents and performing quality checks with increased complexity
• Ability to manage competing priorities in a fast-paced environment
• Ability to travel up to 5% for site visits and events as needed
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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 $59,000 to $83,000 (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.