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 and aortic regurgitation impact 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 Associate Analyst, Clinical Device Management , 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 located at our Irvine headquarters. Candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute onsite.
How you'll make an impact:
Partner with stakeholders to manage inventory and device accountability for sites
Maintain device documentation in the Trial Master File
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, Clinical Implant Specialist)
Provide training on device accountability process for cross functional team members (e.g., clinical specialist and field monitors) and site personnel
Identify, develop, recommend, and implement basic process 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 assigned by leadership ?
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 an ERP software (i.e., JD Edwards), Salesforce.com, electronic TMF (Veeva Vault), and CTMS (Clinical Trial Management System)
Understanding and knowledge of clinical device accountability
Good understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management
Possess 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 including Excel, Outlook, PowerPoint and Visio
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
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 $57,000 to $80,000 (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.