Clinical Data Manager
1 settimana fa
NTWK, azienda italiana operante nella ricerca e selezione del personale, si occupa di soddisfare le necessità dei clienti offrendo servizi personalizzati. 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 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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Beinasco, Italia Altro A tempo pienoCPM, part of the multinational Dürr group, is a global leading supplier of automotive assembly systems which provides high‑innovative products and services covering all the important stages of vehicle production.We’re looking for a Project Manager who will work closely with the project stakeholders to guarantee the overall project success. The Project...
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Beinasco, Italia Dürr Turin A tempo pienoCPM, part of the multinational Dürr group, is a global leading supplier of automotive assembly systems which provides high-innovative products and services covering all the important stages of vehicle production.We're looking for a Project Manager who will work closely with the project stakeholders to guarantee the overall project success. The Project...
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Project Manager
3 settimane fa
Beinasco, Italia Altro A tempo pienoCPM, part of the multinational Dürr group, is a global leading supplier of automotive assembly systems which provides high‑innovative products and services covering all the important stages of vehicle production.We’re looking for a Project Manager who will work closely with the project stakeholders to guarantee the overall project success. The Project...
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Project Manager
4 settimane fa
Beinasco, Italia Dürr Turin A tempo pienoCPM, part of the multinational Dürr group, is a global leading supplier of automotive assembly systems which provides high-innovative products and services covering all the important stages of vehicle production. We're looking for a Project Manager who will work closely with the project stakeholders to guarantee the overall project success. The Project...
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Project Manager
4 settimane fa
Beinasco, Italia Dürr Turin A tempo pienoCPM, part of the multinational Dürr group, is a global leading supplier of automotive assembly systems which provides high‑innovative products and services covering all the important stages of vehicle production. We’re looking for a Project Manager who will work closely with the project stakeholders to guarantee the overall project success. The Project...
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Project Manager
2 settimane fa
Beinasco, Italia Altro A tempo pienoCPM, part of the multinational Dürr group, is a global leading supplier of automotive assembly systems which provides high‑innovative products and services covering all the important stages of vehicle production. We’re looking for a Project Manager who will work closely with the project stakeholders to guarantee the overall project success. The Project...
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Project Manager
3 settimane fa
Beinasco, Italia Dürr Turin A tempo pienoCPM, part of the multinational Dürr group, is a global leading supplier of automotive assembly systems which provides high‑innovative products and services covering all the important stages of vehicle production. We’re looking for a Project Manager who will work closely with the project stakeholders to guarantee the overall project success. The Project...
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Project Manager
2 settimane fa
Beinasco, Italia Dürr Turin A tempo pienoCPM, part of the multinational Dürr group, is a global leading supplier of automotive assembly systems which provides high‑innovative products and services covering all the important stages of vehicle production. We’re looking for a Project Manager who will work closely with the project stakeholders to guarantee the overall project success. The Project...
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Project Manager
2 settimane fa
Beinasco, Italia Dürr Turin A tempo pienoCPM, part of the multinational Dürr group, is a global leading supplier of automotive assembly systems which provides high-innovative products and services covering all the important stages of vehicle production. We’re looking for a Project Manager who will work closely with the project stakeholders to guarantee the overall project success. The Project...
