Analyst, Clinical Data Mgmt

Position Title: Analyst, Clinical Data Mgmt.
Work Location: Irvine, CA 92606
Assignment Duration: 12 Months (Temp to Hire)
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.

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $40.00/hr – $44.00/hr.