Study Start-Up Manager

14 ore fa

Bardi, Italia Novartis A tempo pieno

Job Description Summary Novartis seeks an 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.The role involves trial and budget planning, ensuring on-schedule completion of trial start-up activities, and aligning all start-up deadlines and results with Novartis commitments.Key ResponsibilitiesSteer all SSUs of assigned projects in close cooperation with the SSO Feasibility Manager, SSO Site Partnership Manager, and the global study team.Back 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).Collaborate 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.Ensure timely startup activities from country allocation to the Green Light stage for assigned projects.Facilitate close collaboration with local IRBs/IECs and Health Authorities where necessary.Ensure efficient startup activities, including overseeing the preparation of initial/amendments submission packages and consent form reviews.Coordinate timely responses to deficiency letters working closely with local and global partners.Responsible for 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.Why NovartisOur purpose is to reimagine medicine to improve and extend people's lives, and our vision is to become the most valued and trusted medicines company in the world.Join us to drive our mission, building an inclusive, diverse workplace where people are empowered to achieve our ambitions.Benefits and RewardsExplore detailed information about Novartis Life benefits and rewards to learn more about our inclusive, supportive programs.#J-*****-Ljbffr

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