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.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

As the Associate Analyst, Clinical Device Management, you will develop device processes associated with clinical trials. Ensure compliance with regulations and manage the lifecycle of devices. This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.

How you'll make an impact:

• Regular communication cadence with sites to resolve basic queries

• Investigate and analyze discrepancies between site and JDE data on device accountability in collaboration with stakeholders (e.g., Finance, Customer Service) E/NE

• Provide training on device accountability process within electronic database (e.g., SalesForce) for cross functional team members (e.g., clinical specialist and field monitors)

• Identify, develop, recommend, and implement basic process development and process improvement solutions to trial workflow timelines (e.g., device accountability data) E/NE

• Partner with Quality to resolve device related issues

• Compile (NE) and analyze accurate date of regulatory reports for submission for the regulatory bodies (e.g., FDA) E/NE

• Other incidental duties

What you’ll need (required):

• Bachelor's Degree in related field

•  1 year of work experience with previous clinical trial management experience

What else we look for (Preferred):

• Experience with iOS Apple products, including proficiency in using applications on iPad

• Experience managing clinical trials within medical device industry

• Understanding and knowledge of clinical device accountability

Additional Skills:

• Good computer skills in usage of MS Office Suite including Excel, JDE, electronic database (e.g., Salesforce) required

• Good written and verbal communication skills and interpersonal relationship skills

• Problem-solving and critical thinking skills

• Understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management

• Ability to manage confidential information with discretion

• Good knowledge of regulatory requirements (e.g., CFR, GCP) and documents

• Good knowledge in Microsoft Office Suite, including Excel, JDE, electronic database (e.g., Salesforce) required

• 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 $57,000 to $82,000 (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.