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    Clinical Operations Manager - Irvine, United States - Edwards Lifesciences

    Edwards Lifesciences
    Edwards Lifesciences Irvine, United States

    3 weeks ago

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    Description
    Innovation starts from the heart.

    Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what's currently possible, and create solutions for patients many years into the future.

    If you're an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career.

    We'll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

    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.

    As the Clinical Operations Manager in Advanced Technology (AT), you'll be responsible for managing clinical related activities to provide a platform for study success.

    Please note - the position is a subject matter expert (SME) role and will not have any people management duties.

    This role is on-site at our Irvine headquarter full time 4 days with 1 WFH day/week.

    How you will make an impact:
    Lead clinical operation projects including quarterly audits, annual vendor reviews, etc.

    to support clinical studies and business initiativesOversee device management activities to ensure devices are shipped in a timely fashion for every caseOversee trial training documents to ensure that we're aligned with training matrix(es) and company SOPsMonitors for the overall completeness and inspection readiness of the clinical trial master filesProvide guidance, mentorship and oversight to more junior clinical operations staff membersManage the timely execution of key study milestones through management of performance metrics, to ensure effectiveness, LMS compliance, and TMF qualityPlan, oversee, and lead in the development of procedures and supportive training materials (e.g., work instructions, forms, templates and operational processes) that implement clinical process improvementLead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues in collaboration with cross functional and/or matrix teamsFacilitate the creation of training materials related to the planning and conduct of the trial for the internal research team.

    Conduct training for internal staff and coordinate and present at department team meetingsWhat you will need (Required):

    Bachelor's Degree in related field PLUS 8 years of relevant clinical trial operations/clinical research/clinical monitoring experienceWhat else we look for (Preferred):Experience working in the medical device industry1-2 years of project management leadership experienceProven expertise in Microsoft Office Suite and related clinical tools and systems (e.g., Veeva, CTMS, RAVE)Extensive understanding of clinical studies procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own disciplineExcellent written and verbal communications skills, including negotiating and relationship management skillsExcellent interpersonal skillsExcellent critical thinking and problem solving skillsAbility to travel up to 15%Ability to work on-site 4 days and 1 WFH day/weekCovid-19 vaccination 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 $115,000 to $150,000 (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 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.

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