Clinical Data Analyst

Job Description

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.