SSO Clinical Project Manager

6 days ago

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Kerr Dental

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Endodontics • Dental Restoratives • Treatment units • Infection Prevention • Dental Instruments

1001 - 5000

💰 Debt Financing on 2005-12

Description

• The Study & Site Operations (SSO) Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting of assigned Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements. • The CPM is the single point of contact and study team lead for the assigned studies. • Accountable for execution and reporting of assigned GDD studies in E2E product line Clinical Operations Program Head/Study Lead/ CPM – CRA. • Supports SSO Study Start-up Manager in the development of country/cluster/hub study execution plans and timeline commitments. • Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for getting approval from the Study Leader on enrolling above site targets. • Conducts or coordinates training for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards. • Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study conduct.

Requirements

• A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable • Fluent in both written and spoken English • Minimum 5 years’ experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials • Capable of leading in a matrix environment, without direct reports and working cross-border managing study 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 internal and external (site relationships) • Communicates effectively in a local/global matrixed environment

Benefits

• sign-on bonus • restricted stock units • discretionary awards • full range of medical benefits • 401(k) eligibility • paid time off benefits