Location - Irvine, CA, 92606 (hybrid 3 days onsite)
Summary:
The main function of a clinical data analyst is to create moderately complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide basic recommendations to improve data status during study conduct.
Key Responsibilities:
Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution
Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
Lead project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations (10%)
6. Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base
Participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.
Skills:
• Experience with EDC (Electronic Data Capture) systems required
• Good computer skills in Microsoft Office Suite
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
Education and Experience:
• Bachelor's Degree or equivalent
• 2-4 years of experience required
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Analyst
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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