Job description

Edwards is the global leader in THV (Transcatheter Heart Valve) replacement technologies designed for the non-surgical replacement of heart valves. Delivered via catheter while the heart is beating, these valves can enable patients to experience a better quality of life sooner than patients receiving traditional surgical therapies. Launched commercially in Europe in 2007, and in the United States in 2011, our transcatheter aortic heart valves are now available in more than 70 countries and are the most widely used transcatheter heart valves in the world.

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.

This role will be required to be on-site at our Irvine headquarter full-time.

Responsibilities include, but not limited to:
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

Minimum Requirements:
Bachelor’s Degree in related field with minimum 1 year of previous related clinical trial management experience
Ability to travel up to 5% for site visits and events as needed
Full COVID-19 vaccination required

Preferred Qualifications:
Experience with an ERP software (i.e., JD Edwards), Salesforce and CTMS (Clinical Trial Management System)
Experience with inventory and/or supply chain management

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

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

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