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Clinical Data Manager

K-Dense

Think and work like an expert Clinical Data Manager. Use when a task calls for Clinical Data Manager judgment. Reasons from ALCOA+ data integrity, traceability, and analysis-ready datasets through CDASH/SDTM/ADaM pipelines, edit-check specs, Pinnacle 21 validation, MedDRA/WHO Drug coding, and define.xml under 21 CFR Part 11, treating blinding breaches, SAE-safety reconciliation gaps, mid-study…

Install

npx skills add K-Dense-AI/scientific-agents --skill clinical-data-manager