Edwards Lifesciences Clinical Data Manager - Transcatheter Mitral & Tricuspid Therapies (TMTT) in Irvine, California
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.
The Clinical Data Manager will translate Clinical study business requirements into system requirements for the collection and management of data from Clinical trials. Ensure the quality and integrity of data collected in Clinical studies, the privacy of patient data and efficient recording and reporting of safety related issues.
This position is located in our Irvine, CA office
Define data collection requirements (Case report forms (eCRFs), edit checks and collection of external data) for assigned studies; including defining, performing, and/or coordinating user acceptance testing to ensure appropriate data are collected. Develop and maintain required documentation of these activities (Test plan, summary)
Lead project management activities for a project or multiple (multi-site) projects to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders
Develop and maintain Data Management plans (DMPs), CRF completion guidelines, training materials and user aids in compliance with study design and regulations
Review data for completeness and accuracy
Create moderately complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide basic recommendations to improve data status during study conduct
Evaluate data errors and collection issues; present findings/ recommendations to clinical teams and management for resolution
Participate in development and review of SOPs, work instructions, and associated data management documents including recommending revisions and updates to SOPs, participating in the development of user training.
Bachelor's Degree 3 years of previous related experience in clinical research including clinical data management and/or clinical data entry required
Experience with with EDC (Electronic Data Capture) systems is required, preferably Medidata Rave.
Knowledge and understanding of policies, procedures and guidelines relevant to clinical research
Knowledge of processes and procedures in clinical data management
Knowledge of protocols, data management plans (DMPs), and statistical analysis plans (SAPs)
Strong understanding of Clinical Trial Data management process and experience in EDC platforms, (Medidata Rave, Oracle Clinical EDC system)
Proven expertise in Microsoft Office Suite, especially Excel and PowerPoint
Excellent written and verbal communication skills and interpersonal relationship skills
Strong problem-solving and critical thinking skills
Ability to manage competing priorities in a fast-paced environment
Strict attention to detail
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Ability to build productive internal/external working relationships
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.