Clinical Project Manager
2 mesi fa
col-wideJob Description:
Il Clinical Project Manager è una figura fondamentale nella conduzione dei trial clinici, con un ruolo cruciale nel garantire che gli studi siano eseguiti in conformità con le normative e gli standard di qualità.
Responsabilità principali:
* Pianificazione e coordinamento dello studio clinico, inclusa l'identificazione dei siti investigativi e la gestione delle tempistiche di avvio e chiusura.
* Supervisione del budget e organizzazione del personale coinvolto nello studio.
* Monitoraggio continuo per assicurare la conformità al protocollo e la correttezza dello svolgimento dello studio.
* Effettuazione di visite di monitoraggio per verificare l'aderenza al protocollo, la raccolta dei dati e la sicurezza dei pazienti.
* Aggiornamento e verifica della documentazione di studio, garantendo la sua completezza e conformità alle normative vigenti.
* Formazione e supporto ai ricercatori e al personale coinvolto, se richiesto.
* Assicurazione dell'integrità e accuratezza dei dati raccolti.
* Comunicazione regolare con il team di ricerca, medici, ricercatori e sponsor dello studio.
* Presentazione dei risultati al comitato direttivo dello studio clinico.
* Garanzia del rispetto delle linee guida etiche e legali durante tutto il processo di ricerca.
Requisiti richiesti:
* Laurea in discipline scientifiche;
* Un'esperienza minima di 5 anni in ruoli analoghi, con responsabilità di gestione completa degli studi nelle varie fasi.
* Esperienza nel settore del microbioma, della salute intestinale e dei probiotici sarà considerata un plus.
Competenze tecniche:
* Conoscenza approfondita della terminologia medica e dell'anatomia.
* Comprensione dei processi di sviluppo dei farmaci e della farmacologia.
* Solida conoscenza dei principi scientifici e medici.
* Familiarità con le normative nazionali e internazionali che regolano la ricerca clinica.
* La padronanza di più lingue, in particolare l'inglese, rappresenta un vantaggio.
Soft skills:
* Problem solving
* Gestione dei progetti
* Ottime capacità di comunicazione
* Creatività
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