Analyst, Clinical Device Management

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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 Clinical Device Management Analyst, you will play a pivotal role in developing and optimizing device management processes that support clinical trials. You'll ensure full compliance with regulatory requirements while overseeing the complete lifecycle of clinical devices-from deployment to return.

This is a hybrid position combining remote work with onsite collaboration. The selected candidate must live within a reasonable commuting distance of our Irvine Corporate location and be available for required onsite days.

How You Will Make An Impact

• Analyze clinical device data and notify cross functional team members (e.g., CRA, CS, and/or site coordinator) for data updates/changes
• Partner with Quality to resolve device related issues
• Identify, develop, recommend, and implement moderately complex 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.)
• Develop training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff
• Provide training on device accountability process within electronic database (e.g., SalesForce) for cross functional team members (e.g., clinical specialist and field monitors)
• Compile and analyze accurate date of regulatory reports for submission for the regulatory bodies (e.g., FDA)
• Identify technical and data issues and collaborate with appropriate team members to bring to resolution
• Assist in the determination of root cause and recommend and implement corrective actions
• Develop basic timeline assessment and/or work with senior level team members on complex timeline assessment (e.g., transition to new device system, system enhancements, etc.) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines
• Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables.
• Other incidental duties
  
  

What You'll Need (Required)

• Bachelor's Degree in related field with 3 of previous clinical trial management experience, or equivalent work experience based on Edwards criteria
  
  

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
• Proven expertise in Microsoft Office Suite, including Excel, JDE, electronic database (e.g., Salesforce) required
• Good written and verbal communication skills and interpersonal relationship skills
• Demonstrated problem-solving and critical thinking skills
• Moderate understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management
• Moderate understanding and knowledge of clinical device accountability
• Moderate problem-solving, organizational, analytical and critical thinking skills
• Moderate understanding of regulatory requirements (e.g., CFR, GCP) and documents
• Moderate knowledge in Microsoft Office Suite, including Excel, JDE, electronic database (e.g., Salesforce) required
• Good written and verbal communications skills
• Moderate problem-solving skills
• Ability to manage confidential information with discretion
• 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 inter-departmental teams and representing the organization on specific projects
• 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 $72,000 to $98,000 (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.

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