Study Start-Up Manager

6 ore fa

Milan, Italia Altro A tempo pieno

Job Description SummaryNovartis seeks a dynamic and experienced SSO Study Start‑Up Manager (SSUM) to join our dedicated team. This pivotal position reports directly to the Study Start‑Up (SSU) Team Lead and leads the local Study Start‑Up teams for designated trials holding significant responsibilities within our organization ranging from trial and budget planning to ensuring on‑schedule completion of trial start‑up activities.Job DescriptionKey responsibilitiesThe SSUM is responsible for study planning SSU processes and activation of assigned projects ensuring compliance with Novartis standards GCP / ICH guidelines and regulatory requirements.Your duties will but not be limited toSteering all SSUs of assigned projects in close cooperation with the SSO Feasibility Manager SSO Site Partnership Manager and the global study team.Backing the country’s SSU strategy working closely with the SSO Study Start‑Up Team Lead SSO SSU Country Head and SSO Country Head Portfolio (Early & Late Stage).Collaborating with the SSO Country Head Portfolio SSO Portfolio Team Leads and the global study team to ensure the SSU schedules and results meet country commitments.Responsible for timely startup activities from country allocation to the Green Light stage (ready to initiate site) in assigned projects.Facilitating close collaboration with local IRBs / IECs and Health Authorities where necessary.Ensuring efficient startup activities including overseeing the preparation of initial / amendments submission packages and consent form reviews.Coordinating timely responses to deficiency letters working closely with local and global partners.Responsible for the timely accurate and high‑quality country TMF documents ensuring readiness for inspection while adhering to financial standards prevailing legislation ICH / GCP guidelines local / National Health Authorities regulations and Novartis standards.Essential requirementsA degree in a scientific / healthcare discipline with experience in clinical operations or project management.Minimum of 5 years experience in clinical operations in a project management role and / or in monitoring clinical trials.Skilled in leading in a matrix environment without direct reports.Understanding of all aspects of clinical drug development with a specific emphasis on trial set‑up execution and monitoring.Proven problem‑solving skills and ability to handle complex issues.Understanding of the international aspects of the drug development process including solid knowledge of international standards (GCP / ICH) Health Authorities (FDA / EMEA) local / National Health Authorities regulations and Novartis standards.Employment Type: Full‑TimeVacancy: 1#J-18808-Ljbffr

  • Study Start-Up Manager

    4 settimane fa

    Milan, Italia Altro A tempo pieno

    Job Description SummaryNovartis seeks a dynamic and experienced SSO Study Start-Up Manager (SSUM) to join our dedicated team. This pivotal position reports directly to the Study Start-Up (SSU) Team Lead and leads the local Study Start-Up teams for designated trials holding significant responsibilities within our organization ranging from trial and budget...

  • Procurement Bidding

    1 settimana fa

    Milan, Italia Webuild A tempo pieno

    Webuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l'energia idroelettrica, l'acqua, i green buildings, il tunneling.Espressione di 117 anni di esperienza ingegneristica applicata in 50 paesi dei cinque continenti, grazie al...

  • Procurement Specialist | Bidding

    4 settimane fa

    Milan, Italia Architettura, pianificazione e costruzione A tempo pieno

    Webuild is a global construction player specialized in building large works and complex infrastructure for the sustainable mobility, hydroelectric energy, water, green buildings and the tunnelling sectors. Webuild is the expression of 120 years of engineering experience applied in 50 countries, in five continents, thanks to the talent of 91,000 people from...

  • Procurement Specialist | Bidding

    2 settimane fa

    Milan, Italia Webuild A tempo pieno

    Webuild is a global construction player specialized in building large works and complex infrastructure for the sustainable mobility, hydroelectric energy, water, green buildings and the tunnelling sectors.Webuild is the expression of 120 years of engineering experience applied in 50 countries, in five continents, thanks to the talent of 91,000 people from...

  • Procurement Bidding

    4 settimane fa

    Milan, Italia Architettura, pianificazione e costruzione A tempo pieno

    Webuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l’energia idroelettrica, l’acqua, i green buildings, il tunneling.Espressione di 117 anni di esperienza ingegneristica applicata in 50 paesi dei cinque continenti,...

  • Procurement Bidding

    1 settimana fa

    Milan, Italia Architettura, pianificazione e costruzione A tempo pieno

    Webuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l’energia idroelettrica, l’acqua, i green buildings, il tunneling.Espressione di 117 anni di esperienza ingegneristica applicata in 50 paesi dei cinque continenti,...

  • International Business Development Manager

    3 settimane fa

    Milan, Italia Clutch A tempo pieno

    Per una start up italiana in forte crescita nel settore delle tisane e infusi biologici di alta qualità, stiamo cercando un/a International Business Development Manager . L’azienda si distingue per la selezione meticolosa delle materie prime, l’attenzione alla sostenibilità e un approccio contemporaneo al benessere naturale. La figura avrà un ruolo...

  • International Business Development Manager

    4 settimane fa

    Milan, Italia Clutch A tempo pieno

    Per una start up italiana in forte crescita nel settore delle tisane e infusi biologici di alta qualità, stiamo cercando un/a International Business Development Manager . L’azienda si distingue per la selezione meticolosa delle materie prime, l’attenzione alla sostenibilità e un approccio contemporaneo al benessere naturale. La figura avrà un ruolo...

  • International Business Development Manager

    4 settimane fa

    Milan, Lombardy, Italy, Provincia di Milano Clutch A tempo pieno

    Per una start up italiana in forte crescita nel settore delle tisane e infusi biologici di alta qualità, stiamo cercando un/a International Business Development Manager . L’azienda si distingue per la selezione meticolosa delle materie prime, l’attenzione alla sostenibilità e un approccio contemporaneo al benessere naturale. La figura avrà un ruolo...

  • Operations Engineer, AMZL Start Up Execution

    1 settimana fa

    Milan, Italia Vendita al dettaglio e all'ingrosso Import-export A tempo pieno

    Operations Engineer, AMZL Start Up ExecutionJob ID: | Amazon.com Services LLCAmazon created one of the most sophisticated supply chains in the world. From the introduction of Amazon Prime, to the use of advanced technology for package delivery, Amazon consistently drives change from the front of the pack.As an Amazon Logistics (AMZL) Operations Engineer, you...