Study Start Up Lead

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b87hy

Experteer Overview In this role, you drive efficient, compliant country-level study start-up for clinical trials, collaborating with cross-functional teams to align with global goals. You will lead regulatory submissions, site activation strategies, and vendor coordination to enable timely trial delivery. You shape processes through innovation and automation while maintaining strong regulatory compliance. This is an opportunity to contribute to Roche's mission of improving access to healthcare and advancing science at scale.
Benefits Lead country study start-up strategies, mitigate risks and ensure timely site activation aligned with global goals
Oversee clinical trial submissions and amendments; manage regulatory queries and ensure compliance (ICH‐GCP, EUCTR)
Manage site documentation,



local vendor coordination and translation/approval of patient‐facing materials
Oversee site budgets (FMV‐based), negotiate contracts (CDAs, indemnity/insurance) and maintain forecasting data
Identify process automation opportunities, harmonize systems with global counterparts, and engage with Ethics Boards and Health Authorities
Responsibilities Degree in Life Sciences or equivalent
3–4years of clinical trial start-up, regulatory submissions, and CRO/vendor management
Strong knowledge of ICH‐GCP, EUCTR, IVDR/MDR, and local regulatory environments
Requirements 14‐month salary
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b87hy