Google Cloud PlatformGCPGoogle CloudSSOProject ManagementNegotiation
About this role
Role Overview
Accountable for the day-to-day planning, executing and reporting, of assigned Global Drug Development (GDD) studies
Supports SSO Study Start-up Managers in the development of country/cluster/hub study execution plans and timeline commitments
Proactively identifies risk and opportunities for the assigned studies within the country/cluster/hub and develops respective mitigation plans
Drives the conduct of the study to ensure all study operational aspects are on track
Ensures recruitment targets are met and reviews enrollment at the site level
Oversees local study team activities to achieve study timelines and quality execution
Maintains oversight of country/cluster/hub level data management activities
Coordinates the study handover process with CRAs and their managers
Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution.
Requirements
A minimum of a bachelor's degree in scientific or health discipline
Fluent in both written and spoken English
Minimum 5 years’ experience in clinical research overseeing (project management) and/or monitoring clinical trials
Capable of leading in a matrix environment, without direct reports and working cross-borders managing global studies in various countries
Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
Demonstrated negotiation and conflict resolution skills both internally and externally (site relationships).
Tech Stack
Google Cloud Platform
Benefits
Health insurance
Life and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays and other leaves.