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Clinical Data Analyst

Edwards Lifesciences
3 days ago
Contract
On-site
Irvine, California, United States
$40 - $45 USD hourly

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.

 


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