Angela Germinario
Sr Regulatory Submissions Manager @Medpace
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WORK HISTORY
Sr Regulatory Submissions Manager @Medpace
Milano, IT
Responsible for management of Regulatory Submissions Coordinators and Clinical Trial Assistants. Lead and coordinate departmental initiatives related to process building/improvement and integration of new processes for applicable region. Responsible for maintaining effective communication with Director Regulatory Submissions being aware at all times of critical issues confronting projects and action plans that have been put in place to address those critical issues. Responsible for providing budget estimates for bid proposals and presents proposals to Sponsors.
EDUCATION
Università degli Studi di Firenze
Laurea in Scienze Biologiche
SKILLS
ABOUT ANGELA GERMINARIO
As Sr. Regulatory Manager at Site Activation & Maintenance Department, responsible as RSC and Line Manager with a strong focus on staff performance, goal setting, people development, training/onboarding and resource management, building a fully effective team, evaluating and forecasting resource needs and managing team\'s workload. Review regulations to develop solutions and operation flows to solve issues, challenges and reach the KPI of site activation and quality. Determine project delivery strategy and develop proactive solutions for countries submission and site activation risks in accordance with pertinent regulations and guidelines. Coordinate and oversee clinical trial submission activities, which include providing advice and guidance to internal and Sponsor teams to ensure compliance with appropriate regulations and requirements.
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