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Associate Analyst, Clinical Device Management (Irvine, US) - Transcatheter Heart Valve (THV)

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: November 26, 2022

Job Description:

Associate Analyst, Clinical Device Management (Irvine, US) - Transcatheter Heart Valve (THV)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 roll will be required to be on-site at our Irvine headquarter 5 days/week during training (up to a year) and will reduce to 4 days/week after training.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 requiredPreferred Qualifications:
      • Experience with an ERP software (i.e., JD Edwards), Salesforce and CTMS (Clinical Trial Management System)
      • Experience with inventory and/or/ supply chain managementAdditional 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/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.

Keywords: Edwards Lifesciences Gruppe, Irvine , Associate Analyst, Clinical Device Management (Irvine, US) - Transcatheter Heart Valve (THV), Professions , Irvine, California

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