Senior Clinical Data Management Analyst

Edwards Lifesciences; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, seeks a data management professional to support clinical data management within the TMTT portfolio. You will define data collection needs, oversee data quality, and collaborate with investigators, regulatory authorities, and the clinical team to enable robust evidence generation.

The role emphasizes multi-site project leadership, SOP development, and training material creation.

Qualifications

• Bachelor’s Degree in related field with 5 years of previous related experience in clinical research including clinical data management and/or clinical data entry or equivalent work experience based on Edwards criteria.
• Experience with EDC (Electronic Data Capture) systems

Responsibilities

• Creating complex metrics to identify trends in data and remediation, utilizing tools to assess need for training and providing recommendations to improve data status during study conduct.
• Defining and specifying clinically complex data collection requirements (eCRFs, CRFs, edit checks) for assigned studies and coordinating user acceptance testing.
• Leading project management activities for multiple projects to bring clinical studies on-line, including meetings, timelines, and stakeholder communications.
• Developing and maintaining Data Management deliverables including data management plans, training materials and user aids in compliance with regulations.
• Evaluating data errors and collection issues; providing guidance to clinical team for resolution.

Skills

Communication skills

Interpersonal skills

Team collaboration

Attention to detail

Education

Bachelor’s Degree in related field

Tools

EDC systems

AI tools Copilot & Claude

Job description

Edwards Lifesciences in Irvine, CA, seeks a data management professional to support clinical data management within the TMTT portfolio. You will define data collection needs, oversee data quality, and collaborate with investigators, regulatory authorities, and the clinical team to enable robust evidence generation.

The role emphasizes multi-site project leadership, SOP development, and training material creation.