Please submit your application in English
What You'll Do: Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level
Review/prepare local submission documents and performs submissions (Initial submissions, Substantial Amendments and Notifications etc.) to Ethics Committees (Central and Local) and to Competent Authority for Clinical Trials/RWE in accordance with local country requirements (e.g. via portal upload or mail or Email); and deliver final submission package to RASSU Specialist assigned to the study
Identify the Central and Local Ethics Committees and Competent Authority needed for the study on the country level; process pre-payments to Ethics Committees and Competent Authority; adapts study-related documents (e.g. Informed Consent Forms) to meet each local country's specifications in cooperation with the RASSU Specialist assigned to the study




Serve as applicant for Clinical trials/RWE and may act as main point-of-contact for the Ethics Committees and Competent Authority and the assigned RASSU Specialist to the study on the country level
Communicate closely with RASSU specialist assigned to the study regarding EC /CA outcomes
Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper
QC and QA of various study related Regulatory documents and reports
Perform review, reconciliation, close-out, and archiving activities of study or project
Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
Attends internal and external study meetings and regulatory status reports for each site and country during study meetings
Support the CTI Legal team: Foster relationships with key contacts at each site
Facilitate contract-related communication between the site and CTI
Assist with site contract translation; track the pr

📌 Country Study Start-Up Specialist I (Milano)
🏢 Altro
📍 Milano