Study start up lead
Pubblicato il 01-08-2026 - Experteer Italy in Italia
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 #J-18808-Ljbffr