Clinical Data Management Analyst, Classic/New Medidata RAVE EDC 19151

Job ID: 19151-1
Job Title: Clinical Data Management Analyst
Job Length: 1 Year (Renewable)
Compensation: Up to
Summary: Up to $48/hr.
Location: Irvine, CA 92606

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 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.
• 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.

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 with using AI tools like CoPilot, Claude to support clinical trial activities is preferred.

Education and Experience:

• Bachelor's Degree or equivalent.
• 2-4 years of experience required.

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Work Location: In person

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