Job Information
Edwards Lifesciences Manager, Clinical Data Management, Critical Care (Remote USA) in Irvine, California
For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.
With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.
As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability. We are well-positioned to build upon our category leadership as we continue to launch new solutions powered by A.I. to clinicians and expand into new care settings.
So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industry-leading advanced monitoring company we invite you to explore our career opportunities. Those who choose to join us will be part of a ‘once-in-a-lifetime’ journey to improve the quality of care and outcomes for millions of patients around the world.
Appendix:
For further detail on the spin-off of Critical Care from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99 (https://ir.edwards.com/events-presentations/event-details/2023/Edwards-Lifesciences-2023-Investor-Conference-2023-bK2BbXaBha/default.aspx) .
How you will make an impact:
The Manager, Clinical Data Management will be responsible for managing and conducting data-related activities for multiple clinical trials to ensure data availability, quality, accuracy, and compliance.
Provide functional expertise and lead the activities for complex collection data requirements and/or testing (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies.
Review and clean data according to DMP (Data Management Plan), SOPs and associated documents using the clinical data management system, listings, and reports.
Lead project management activities for multiple complex projects to bring clinical studies on-line.
Develop Data Management deliverables including data management plans (DMPs), training materials and user aids. Train internal staff and external users.
Provide training, mentorship, and guidance to lower-level staff.
Identify and make recommendations on trends in data discrepancies and remediation, including developing instruments, and training requirements across studies and therapeutic areas to ensure uniformity in approach and execution.
Develop and lead the review of SOPs, work instructions, process improvements and associated procedures for CDM.
Manage CDM related requests from external stakeholders (e.g., regulators, notified bodies, non-governmental agencies, core labs, independent study committee).
What you'll need (Required):
Bachelor's Degree in related field, 8 years’ experience of previous related experience in clinical research including clinical data management.
Experience with EDC (Electronic Data Capture) systems and software testing in a clinical research or clinical data management environment.
Experience authoring DMPs, SOPs, and training materials.
What else we look for (Preferred):
Extensive knowledge and understanding of processes and procedures in clinical data management.
Proven successful project management skills.
Experience with Medidata Rave.
Extensive knowledge and understanding of protocols, DMPs, and SAPs.
Extensive understanding of regulatory policies as it relates to CDM processes.
Represents leadership on sections of projects within a specific area interfacing with project managers and clinical data management team.
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
Consult in project setting within specific sections of clinical data management.
Proven expertise in Microsoft Office Suite and related tools and systems.
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 $120,000 to $170,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.
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.
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 15,000 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.