Job Description
Job Description
Position: Clinical Data Analyst, Req# 19151-1
Location: Irvine, CA (2 days onsite, 3 days remote)
Duration: 12+ months contract to hire
Job Description:
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.
Education and Experience:
- Bachelor's Degree or equivalent.
- 2-4 years of experience required.
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 using AI tools like Copilot and Claude to support clinical trial activities is preferred.
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 online, 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.