Clinical Operations Associate, Device Accountability

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.
As the Clinical Device Management Associate Analyst, you will develop and support device processes associated with clinical trials. You will also ensure compliance with regulations and manage the lifecycle of device inventory and accountability to support clinical trials.
The position will be on-site at our Irvine headquarter 4 days with 1 WFH day/week.
How you will make an impact:

• Partner with stakeholders to manage inventory and Device Accountability for sites
• Regularly communicate with site and field team 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, Clinical IT)
• 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 improvement solutions to trial workflow timelines (e.g., Device Accountability data)
• Partner with Quality to resolve device related issues
• Compile and analyze data to support regulatory submissions for the regulatory bodies (e.g., FDA)
• Other incidental duties

What you will need (required):

• Bachelor's Degree in related field with minimum 1 year of previous related clinical trial support or operations experience
• Ability to travel up to 5% for site visits and events as needed

What else we look for (preferred):

• Experience with an ERP software (i.e., JD Edwards), Salesforce and CTMS (Clinical Trial Management System)
• Possess strict attention to detail

Additional skills:

• 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 including Excel, JDE, electronic database (e.g., Salesforce)
• Good understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management
• Ability to manage confidential information with discretion
• Ability to manage competing priorities in a fast-paced environment
• 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 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
• 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, the base pay range for this position is $56,000 to $80,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.