Position Title:

Analyst, Clinical Data Mgmt.

Work Location:

Irvine, CA 92606

Assignment Duration:

12

Months Work Arrangement:

Hybrid / Shared workspace (onsite 40-60% of the time; shared workspace utilized at least 80%)

Position Summary:

The main function of a clinical data analyst is to lead and support clinical data management activities, during study start-up, conduct and closeout, including database lock.

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.

Qualification & Experience:

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