Start Up Specialist - FSP Team - Italy

Job description

The Start Up Specialist serves as the primary point of contact for investigative sites during study start‑up and maintenance activities. The role ensures timely and compliant submission of documentation to EC/IRB/Regulatory Authorities, adherence to applicable regulations and ICH‑GCP standards, and effective collaboration with internal study teams to support site activation and ongoing regulatory maintenance. Key Responsibilities: - Act as the primary contact for investigative sites, ensuring timely collection, quality review, and tracking of all essential start‑up and regulatory documents. - Prepare, compile, and submit regulatory and ethics applications (e.g., EC/IRB/IEC/Regulatory Authority submissions) in accordance with local regulations, sponsor requirements, and agreed project timelines. - Maintain up‑to‑date knowledge of regulatory legislation, guidance, and best practices in assigned countries or regions, serving as a local subject‑matter expert. - Coordinate with internal stakeholders and external vendors to support the generation, review, and submission of regulatory documentation. - Proactively identify, manage, and escalate risks or issues that may impact timelines, de...