Country Study Start-Up Specialist I

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79g1vt

pp Please submit your application in English /ph3What You'll Do: /h3ulliInforms the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level /liliReview/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 /liliIdentify 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 /liliServe 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 /liliCommunicate closely with RASSU specialist assigned to the study regarding EC /CA outcomes /liliAccurately 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 /liliQC and QA of various study related Regulatory documents and reports /liliPerform review, reconciliation, close-out, and archiving activities of study or project /liliOversee translation of regulatory documents, if needed, on behalf of Sponsor,



as agreed to in scope /liliAttends internal and external study meetings and regulatory status reports for each site and country during study meetings /li /ulh3Support the CTI Legal team: /h3ulliFoster relationships with key contacts at each site /liliFacilitate contract-related communication between the site and CTI /liliAssist 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 /liliIdentify any unique investigator, country or site-specific issues and identifying any ancillary agreements that may be necessary /liliAssist with site contract execution /li /ulh3Support Site Budget activities: /h3ulliIdentify and establish relationship with site personnel responsible for budget proposals /liliInteract with project management team members and clinical trials budget manager /liliHas exact knowledge about site specific budget templates and experiences of completing such templates /liliTrain sites to understand budget templates and contents /liliUnderstand and communicate changes made by the site to clinical trials budget managers and vice versa /liliAssisting 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 /ulh3What You'll Bring: /h3ulli1-2 years of experience in Clinical Research (pharmaceutical, site or CRO service)



and experience in regulatory in country. /liliAssociate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience /liliFluent in spoken and written Italian and English /li /ulh3About CTI /h3ulliAdvance Your Career – We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals. /liliJoin an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world. /liliMake a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most. /li /ulh3Important Note /h3p In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an (email hidden) /strong email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( or from our verified LinkedIn page. /ph3Please Note /h3ulliWe will never communicate with you via Microsoft Teams or text message /liliWe will never ask for your bank account information at any point during the recruitment process /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79g1vt