SSO Clinical Project Manager
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Job Description
CPM responsible for planning, executing, and reporting on assigned Global Drug Development studies. Ensures compliance with Novartis processes and regulatory requirements during trial execution.
Responsibilities:
- The CPM is accountable for the day-to-day planning, executing and reporting of assigned Global Drug Development studies
- Responsible for assuring aligned communication with Trial Lead and other CTT members
- Supports SSO Study Start-up Managers in the development of country/cluster/hub study execution plans
- Proactively identifies risk and opportunities for the assigned studies within the country/cluster/hub
- Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs and site personnel
- Drives the conduct of the study, tracks status, maintains relevant reporting systems, oversees forecasts, progress, and mitigation plans
- Ensures recruitment targets are met and reviews enrollment at the site level
- Oversees local study team activities to achieve study timelines and quality execution
- Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution
- Accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports
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)
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
- Performance-based cash incentive
- Eligibility for annual equity awards
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