Clinical Data Analyst

Clinical Data Analyst (JN - Irvine, California

Salary: USD
43.74 - USD
43.74 per hour

W-2 Contract Role

Duration: 12 Months

Location: Irvine, CA 92606

Pay Rate: $43.74/hour

The Clinical Data Analyst will lead and support clinical data management activities throughout the clinical study lifecycle, including study start-up, conduct, closeout, and database lock. This role is responsible for ensuring accurate data collection, data quality, regulatory compliance, and effective project coordination across clinical studies.

• Define and specify clinical data collection requirements, including:
  • eCRFs/CRFs
  • Edit checks
  • External data collection requirements
• Utilize Global Library standards and coordinate User Acceptance Testing (UAT), including test scripts and checklists.
• Review, evaluate, and resolve data discrepancies and collection issues.
• Provide recommendations and guidance to clinical teams regarding data quality and issue resolution.
• Lead data management project activities, including:
  • Clinical study meetings
  • Project timeline management
  • Stakeholder communications
• Develop and maintain Clinical Data Management documentation, including:
  • Data Management Plans (DMPs)
  • Training materials
  • User guides and job aids
• Ensure compliance with applicable regulations and company procedures.
• Perform user access management and internal/external data reconciliation activities.
• Manage and maintain Trial Master File (TMF) documentation and filing requirements.
• Participate in the review and revision of SOPs, work instructions, and related documentation.
• Support user training initiatives and continuous process improvement efforts.

• Bachelor's Degree or equivalent combination of education and experience.
• 2 to 4 years of Clinical Data Management or Clinical Data Analyst experience.
• Experience working with Electronic Data Capture (EDC) systems, including:
  • Medidata RAVE Classic
  • Medidata RAVE EDC (new platform)
• Experience supporting clinical trials and clinical study data management activities.
• Proficiency in Microsoft Office Suite.

• Experience using AI tools such as Microsoft Copilot or Claude to support clinical trial and data management activities.
• Familiarity with clinical trial documentation processes and TMF management.

• Clinical Data Management (CDM)
• Electronic Data Capture (EDC)
• Medidata RAVE (Classic and New RAVE)
• User Acceptance Testing (UAT)
• Database Lock Activities
• Trial Master File (TMF)
• SOP Documentation and Training
• Strong Written and Verbal Communication
• Critical Thinking and Problem-Solving
• Project Coordination and Stakeholder Management