Clinical Data Analyst

Ledgent Technology; Irvine (CA); On-site; USD 51,000 - 69,000; Full time

Job summary

Ledgent Technology in Irvine, CA seeks a Clinical Data Analyst for a 12-month W-2 contract to lead data management activities across the study lifecycle. You will ensure accurate data collection, data quality, and regulatory compliance while coordinating with clinical teams.

Responsibilities include defining data collection requirements, coordinating UAT, resolving data discrepancies, and maintaining DMPs and TMF documentation.

Qualifications

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

Responsibilities

• Define and specify clinical data collection requirements, including eCRFs/CRFs, edit checks, and external data collection requirements.
• Coordinate User Acceptance Testing (UAT) using 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: study meetings, timelines, and stakeholder communications.
• Develop and maintain Data Management documentation (DMPs, training materials, user guides).
• Ensure regulatory compliance and company procedures.
• Perform user access management and data reconciliation, TMF documentation and filing.
• Participate in SOP revisions and training initiatives.

Skills

CDM

EDC

Medidata RAVE Classic

Medidata RAVE EDC

UAT

TMF

SOP Documentation

Training

Education

Bachelor's Degree or equivalent

Tools

Medidata RAVE (Classic)

Medidata RAVE EDC (New)

Job description

Clinical Data Analyst (JN -092026-430355) Irvine, California

Salary: USD43.74 - USD43.74 per hour

Clinical Data Analyst

W-2 Contract Role

Duration: 12 Months

Location: Irvine, CA 92606

Pay Rate: $43.74/hour

Position Summary

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Required Skills

• 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