27 set - Provincia di Latina
Novo Nordisk Pharma
OverviewLegga la panoramica di questa occasione per capire quali competenze sono richieste, incluse le soft skill pertinenti e la padronanza di pacchetti software.In 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.Retribuzione / BenefitsSalary range 53,180.00 to 82,430.00 EURIncentives and benefitsCareer development opportunitiesGlobal healthcare company environmentCollaborative cultureOpportunity to impact patient access to therapiesResponsabilitàManage regulatory authority and ethics committee submissions across projects to obtain timely approvalsCoordinate with internal and external stakeholders to collect, review and submit start-up documents through the CTIS portalEnsure compliance with ICH-GCP, local regulations,
and Novo Nordisk SOPs throughout trial conductionContribute to process improvements and share best practices across local and global start-up teamsMaintain accurate trial master file documentation and start-up tracking systemsCollaborate with monitors, clinical trial administrators, and legal teams to negotiate and finalize site contracts and budgetsEstablish partnerships with clinical trial managers to drive study success and patient impactSupport cross-cultural collaboration and efficient start-up activities across affiliatesRequisiti fondamentali3–5 years' experience in clinical trial start-up, regulatory submissions or clinical operations in pharma/biotechSolid knowledge of ICH-GCP and local regulatory requirementsExperience with regulatory authority and ethics committee xysqume submissions and timelinesStrong organizational skills to manage multiple trials with attention to detailExcellent communication and stakeholder management across cultures and functionsProactive mindset toward digitalisation and AI/digital tools to improve daily workBachelor in Life Sciences, Pharmacy, Nursing or related field (BSc or MSc)Proficiency in Italian and EnglishApplications from other locations in Italy consideredCross-cultural collaborationProactive problem-solvingAttention to detailCTIS portal submissionsICH-GCP complianceTrial master file management
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