Clinical Data Manager

4 giorni fa

Torino, Italia NTWK A tempo pieno

NTWK, azienda italiana operante nella ricerca e selezione del personale, si occupa di soddisfare le necessità dei clienti offrendo servizi personalizzati.

Posizione:

Siamo alla ricerca di un Clinical Data Manager per azienda con sede a Novara (possibilità di lavorare da remoto).

Il Clinical Data Manager (CDM) garantisce l'integrità, la qualità e la conformità normativa dei dati clinici lungo l'intero ciclo di vita dello studio.

Coordina la pianificazione, gestione e archiviazione dei dati secondo le linee guida ICH-GCP, 21 CFR Part 11 e gli standard CDISC (SDTM, ADaM, Define-XML).

Principali Responsabilità

A. Pianificazione dello Studio

  • 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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