Clinical Data Analyst

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

Position: Clinical Data Analyst, Req# 19151-1

Location: Irvine, CA(2 days onsite, 3 days remote)

Duration: 12+ months contract to hire

Job Description:

The main function of a clinical data analyst is to lead and support clinical data management activities during study start-up, conduct and closeout, including database lock.

Education and Experience:

• Bachelor's Degree or equivalent.
• 2-4 years of experience required.

Skills:

• Experience with EDC (Electronic Data Capture) systems required, both Classic and New Medidata RAVE EDC.
• Good computer skills in Microsoft Office Suite.
• Good written and verbal communication skills and interpersonal relationship skills.
• Good problem-solving and critical thinking skills.
• Experience using AI tools like Copilot and Claude to support clinical trial activities is preferred.

Key Responsibilities:

• Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, using Global Library standards and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
• Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution.
• Lead project management activities for clinical studies online, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
• Maintain and develop Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations.
• Perform User Access and data (external and internal) reconciliation.
• Experience with Trial Master File (TMF) for clinical trial documentation and filing.
• Participate in review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.

Why TalentBurst?

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.