Clinical Data Management Analyst

Job Title: Clinical Data Management Analyst

Job Location: Irvine, CA

Job Type: Contract

Job Overview:

Pay Range: $38.76hr - $43.76hr

Requirement/Must Have:

• Bachelor s Degree or equivalent.
• 2-4 years of experience required.
• Experience with EDC (Electronic Data Capture) systems required, both Classic and New Medidata RAVE EDC.
• Good computer skills in Microsoft Office Suite.
• Experience with Trial Master File (TMF) for clinical trial documentation and filing.

Responsibilities:

• Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies.
• Define, perform, and use Global Library standards and coordinate user acceptance testing to ensure appropriate data are collected.
• Evaluate data errors and collection issues and provide guidance and recommendations to clinical team for resolution.
• Lead project management activities for clinical studies on-line, 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.
• Participate in review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs and participating in the development of user training.

Nice to Have:

• Experience with using AI tools like CoPilot or Claude to support clinical trial activities is preferred.

Skills:

• Medidata RAVE EDC.
• Microsoft Office Suite.
• Strong verbal and written communication skills.
• Excellent communication and presentation skills.
• Problem-solving and critical thinking skills.
• AI tools (CoPilot, Claude).

Qualification And Education:

• Bachelor s Degree or equivalent.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities