Senior Study Start-Up Specialist

pIn this role, you drive the study start-up process to enable timely, compliant trial initiation. You manage regulatory and ethics submissions and coordinate cross-functional colleagues to activate sites and enable patient access to investigational therapies. You will operate within a global trial portfolio, supporting continuous improvement and robust trial documentation. You will work closely with local teams in Italy to ensure quality, speed, and regulatory adherence. This is an opportunity to shape early-phase trial readiness and impact patient outcomes. /pulliSalary range 53,180.00 to 82,430.00 EUR /liliIncentives and benefits /liliGlobal healthcare company environment /liliCollaborative culture /liliOpportunity to impact patient access to therapies /liliManage regulatory authority and ethics committee submissions across projects to obtain timely approvals /liliCoordinate with internal and external stakeholders to collect, review and submit start-up documents through the CTIS portal /liliEnsure compliance with ICH-GCP, local regulations, and Novo Nordisk SOPs throughout trial conduction /liliContribute to process improvements and share best practices across local and global start-up teams /liliMaintain accurate trial master file documentation and start-up tracking systems /liliCollaborate with monitors, clinical trial administrators, and legal teams to negotiate and finalize site contracts and budgets /liliEstablish partnerships with clinical trial managers to drive study success and patient impact /liliSupport cross-cultural collaboration and efficient start-up activities across affiliates /lili3–5 years' experience in clinical trial start-up, regulatory submissions or clinical operations in pharma/biotech /liliSolid knowledge of ICH-GCP and local regulatory requirements /liliExperience with regulatory authority and ethics committee submissions and timelines /liliStrong organizational skills to manage multiple trials with attention to detail /liliExcellent communication and stakeholder management across cultures and functions /liliProactive mindset toward digitalisation and AI/digital tools to improve daily work /liliBachelor in Life Sciences, Pharmacy, Nursing or related field (BSc or MSc) /liliProficiency in Italian and English /liliApplications from other locations in Italy considered /liliProactive problem-solving /liliCTIS portal submissions /liliICH-GCP compliance /li /ul #J-18808-Ljbffr