Hybrid Clinical Data Analyst (Medidata RAVE & EDC)

Edwards Lifesciences; Irvine (CA); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Clinical Data Analyst to lead and support clinical data management activities across study start-up, conduct, and closeout, including database lock. The role emphasizes hands-on data governance using EDC systems (Classic and Medidata RAVE) and collaboration with cross-functional teams.

Bachelor’s degree, 2–4 years of experience, and strong communication, problem-solving, and MS Office skills are required; AI tools Copilot/Claude experience is a

Qualifications

• Bachelor's degree or equivalent required.
• 2–4 years of clinical data analytics experience preferred.
• Experience with EDC systems (Classic and Medidata RAVE) is required.

Responsibilities

• Define data collection requirements (eCRFs, CRFs, edit checks) for studies.
• Evaluate data errors and provide guidance to the clinical team.
• Lead online project management and stakeholder communications.
• Develop DMPs, training materials, and user aids for CDM compliance.
• Perform User Access and data reconciliation (internal/external).
• Participate in TMF documentation review and SOP updates.

Skills

EDC systems (RAVE Classic & Medidata)

Microsoft Office

Strong communication skills

Problem-solving

AI tools experience (Copilot/Claude)

Education

Bachelor's degree or equivalent

Tools

TMF (Trial Master File)

Job description

Edwards Lifesciences in Irvine, CA is seeking a Clinical Data Analyst to lead and support clinical data management activities across study start-up, conduct, and closeout, including database lock. The role emphasizes hands-on data governance using EDC systems (Classic and Medidata RAVE) and collaboration with cross-functional teams.

Bachelor’s degree, 2–4 years of experience, and strong communication, problem-solving, and MS Office skills are required; AI tools Copilot/Claude experience is a