Clinical Data Manager
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- Analisi del protocollo e definizione del piano di Data Management (DMP).
- Pianificazione CDISC e sviluppo del flusso dati (SDFD). B. Sviluppo e Validazione Database
- Raccolta requisiti (URS), progettazione e validazione eCRF.
- Gestione modifiche, sviluppo mapping SDTM e test UAT. C. Gestione Qualità Dati
- Monitoraggio continuo e verifica coerenza dati.
- Gestione query e processi di chiarimento con i siti.
- Supervisione codifica medica (MedDRA, WHO Drug).
- Integrazione dati esterni e monitoraggio prestazioni siti. D. Chiusura Database e Archiviazione
- Revisione finale, approvazione del lock e preparazione dataset CDISC.
- Creazione pacchetto regolatorio (RDP) e metadata Define-XML.
- Archiviazione conforme a 21 CFR Part 11. Requisiti: Requisiti e Competenze:
- Esperienza in Data Management clinico e conformità normativa.
- Conoscenza approfondita di SDTM, ADaM, CDASH e Define-XML.
- Capacità di sviluppare DMP e gestire query lifecycle.
- Familiarità con codifica medica e produzione dataset CDISC.
- Esperienza in validazione dati, edit checks e risoluzione query.
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Clinical Trial Manager
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