Manager, Clinical Data Management

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 impacts millions of people globally, yet it often remains under-diagnosed and undertreated. 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.

This role can be either an onsite or hybrid role based at Edwards’ Irvine campus, or a remote-based role in the U.S.

The Manager of Clinical Data Management will be a subject matter expert responsible for managing and conducting data-related activities for multiple clinical trials to ensure data availability, quality, accuracy, and compliance. The successful candidate will lead and oversee data management activities across multiple studies, from study start-ups to database builds and migrations through study closure, supporting clinical trial objectives and corporate goals.

• 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 sala