clinical-data-manager

【数据与研究】Expert-thinking profile for Clinical Data Manager (clinical / research): 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…

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