Senior project manager with 25+ years’ study management experience overseeing complex, deadline-driven projects and clinical studies in the pharmaceutical field. Extensive experience managing clinical trials at large and small biotech and pharmaceutical companies overseeing CROs, functional teams, internal personnel as supervisor (5 years
Senior project manager with 25+ years’ study management experience overseeing complex, deadline-driven projects and clinical studies in the pharmaceutical field. Extensive experience managing clinical trials at large and small biotech and pharmaceutical companies overseeing CROs, functional teams, internal personnel as supervisor (5 years), study start-up activities including preparing study specific protocols and informed consent forms, reviewing study documents, managing clinical sites, managing clinical supplies, preparing and overseeing investigator meetings, driving enrollment, managing study budgets, cross-functional teams and reporting / liaison duties, and assisting with clinical study reports and regulatory submissions. Particularly noted for consistently achieving milestones, meeting project goals and embodying excellence. Well-suited for large-scale and multi-year projects with multiple deadlines, shifting priorities, intermediate objectives and an international component requiring good communication and coordination skills. Specialized experience managing eCOA vendors and eCOA licensing for three years.