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Cynet Systems
Clinical Data Management AnalystCynet Systems • Irvine, CA, United States
Clinical Data Management Analyst

Clinical Data Management Analyst

Cynet Systems • Irvine, CA, United States
3 hours ago
Job type
  • Full-time
Job description

Job Title

Job Overview:

Pay Range: $38.76hr - $43.76hr

Requirement/Must Have:

  • Bachelors 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:

  • Bachelors Degree or equivalent.
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Clinical Data Management Analyst • Irvine, CA, United States

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