Study Start Up

7 giorni fa

Milano, Italia NonStop Consulting A tempo pieno

Azienda internazionale presente sul mercato da oltre 20 anni, sta cercando una figura da inserire come Study Start Up/Regulatory Associate all'interno del dipartimento delle clinical operations.

Tra le varie attivita', avrai il compito di fornire l'elenco dei documenti necessari per la presentazione iniziale a CA e CE per richiedere l'autorizzazione, garantire che la documentazione predisposta per la presentazione a CE e CA sia conforme alla normativa italiana, etc...

Si tratta di una posizione home-based, quindi potrai lavorare ovunque tu voglia.

Entrando a far parte di questa azienda avrai grande opportunita' di crescita, perche' a differenza di altre CRO molto grandi, qui la competizione e' ridotta, il che ti permettera' una velocissima progressione.

**Qualifications**:
Almeno 1-3 anni di esperienza nella regolamentazione/start-up in studi clinici.
Buona conoscenza dei GCP/ICH e delle normative internazionali/locali
Conoscenza aggiornata delle normative nazionali/internazionali relative alle Procedure di Avviamento della Sperimentazione clinica.
Predisposizione della richiesta di autorizzazione alla sperimentazione clinica
Negoziazione del contratto e del budget con i siti secondo necessità
Inglese fluente

Se hai trovato questo profilo interessante, fai domanda qui o sul sito web di NonStop Consulting oppure invialo a me, Anna Di Martino, sul mio Linkedin. Se non sei disponibile ma conosci qualcuno che potrebbe essere interessato, per favore inoltralo a loro aiutando così le persone nella tua rete.

NonStop Consulting è una società di ricerca e selezione di personale paneuropea, pluripremiata e specializzata in diversi settori, tra cui quello scientifico, farmaceutico, chimico, sanitario, tecnico, informatico e finanziario. Dal 2019 abbiamo ampliato la nostra offerta agli Stati Uniti con un ufficio a Boston, Massachusetts.

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