ppb Please submit your application in English /b /p h3WhatYou'llDo: /h3 h3Support of Regulatory Affairs Study Start-Up (RASSU) department: /h3 ul liInforms the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level /li liReview/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 /li liIdentify 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 /li liServe 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 /li liCommunicate closely with RASSU specialist assigned to the study regarding EC /CA outcomes /li liAccurately 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 /li liQC and QA of various study related Regulatory documents and reports /li liPerform review, reconciliation,



close-out, and archiving activities of study or project /li liOversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope /li liAttends internal and external study meetings and regulatory status reports for each site and country during study meetings /li /ul h3Support the CTI Legal team: /h3 ul liFoster relationships with key contacts at each site /li liFacilitate contract-related communication between the site and CTI /li liAssist with site contract translation; track the progress by updating and maintaining internal systems, databases and tracking tools (including the Trial Interactive database) with project specific information /li liIdentify any unique investigator, country or site-specific issues and identifying any ancillary agreements that may be necessary /li liAssist with site contract execution /li /ul h3Support Site Budget activities:



/h3 ul liIdentify and establish relationship with site personnel responsible for budget proposals /li liInteract with project management team members and clinical trials budget manager /li liHas exact knowledge about site specific budget templates and experiences of completing such templates /li liTrain sites to understand budget templates and contents /li liUnderstand and communicate changes made by the site to clinical trials budget managers and vice versa /li liAssisting with translation, tracking the progress by updating the Trial Interactive database, sharing drafts and final versions with CTI personnel and delivering the final negotiated budget to site personnel /li /ul h3WhatYou'llBring: /h3 ul li1-2 years of experience in Clinical Research (pharmaceutical, site or CRO service) and experience in regulatory in country. /li liAssociate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience /li libFluent in spoken and written Italian and English /b /li /ul h3AboutCTI /h3 ul libAdvanceYourCareer /b–Weinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals. /li libJoinanAward-WinningTeam /b–Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.Wesupportyourwork-lifebalancewithhybridworkopportunities.ThroughourCTICaresprogram,you’llhaveopportunitiestogivebacktoyourcommunityandtheworld. /li libMakeaLastingImpact /b–AtCTI,yourworkdirectlycontributestoadvancingmedicine.You’llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.Together,wemovemedicineforward,makingadifferenceforthosewhoneeditmost. /li /ul /p #J-18808-Ljbffr

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