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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 either located in our Irvine, CA office

Key Responsibilities:

  • 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; provide guidance and recommendations to clinical team for resolution

  • Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected

  • Lead project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders

  • Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulationsPerform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base

  • Participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training

Basic Qualifications:

  • Bachelor's Degree 3 years of previous related experience in clinical research including clinical data management and/or clinical data entry required

  • Experience with MediData Rave EDC (Electronic Data Capture) system is required

  • 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)

Preferred Qualifications:

  • Experience with Oracle InForm EDC system

  • Proficiency in Microsoft Office Suite

  • 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.

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