Job Title
Job Overview
Pay Range: $38.76hr - $43.76hrRequirement/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.

Also on the board Same function, level within a rung

Level

Mid

Salary

$38.76hr

Location

Irvine, CA

Occupation

Clinical Data Managers

Industry

Other Scientific and Technical Consulting Services

Posted

8 days ago

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