Clinical Data Manager

3 giorni fa


Milano, Italia Ospedale San Raffaele A tempo pieno

Dettagli offerta di lavoro

Corrispondenza tra il tuo profilo e i dettagli dell'annuncio.

Tipo di contratto

- Tempo pieno

Località

Milano, Lombardia

Descrizione completa della posizione

L'IRCCS Ospedale San Raffaele, struttura clinica-scientifica-universitaria di rilievo internazionale e di alta specializzazione per diverse importanti patologie, sta ricercando un Clinical Data Manager / Clinical Study Coordinator da inserire nella propria Unità Operativa di Chirurgia Vascolare.

Attività principali:
Sottomissione di studi clinici spontanei e sponsorizzati al Clinical Trial Center (CTC) e al Comitato Etico (CE);
Supporto allo staff clinico per la stesura di protocolli spontanei;
Inserimento dati clinici in database elettronici e Case Report Form (CRF);
Report di eventi avversi e eventi avversi seri (SAE);
Collaborazione con il personale delle Contract Research Organization (CRO) per pratiche relative agli studi clinici (sottomissione studi sponsorizzati, visite di inizio studio – SIV, visite di monitoraggio etc.);
Organizzazione visite di arruolamento e di follow-up dei pazienti arruolati.

Cosa non può mancare:
Laurea in discipline scientifiche-biologiche e/o frequentazione di corsi postgraduate o master relativi alla ricerca clinica;
Conoscenza dei concetti base della ricerca clinica (tipi di studi, ruolo delle figure coinvolte – Investigator, PI, CE, CRO etc.);
Conoscenza di base della normativa e dei processi che regolano le sperimentazioni cliniche (Good Clinical Practice, consenso informato, sottomissione al CE, notifiche obbligatorie etc.);
Familiarità con pacchetto Office e programmi di inserimento e gestione dei dati (Excel etc.);
Conoscenza di base della lingua inglese e familiarità nella comunicazione scritta (email) in inglese;
Puntualità e rispetto delle scadenze;
Precisione e gestione autonoma dei compiti assegnati.

Dettagli lavorativi:
Tipologia contrattuale: full-time;
Durata: indeterminato;
Sede: IRCCS Ospedale San Raffaele, via Olgettina, n. 60 - Milano.



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