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Clinical Project Manager
hace 2 meses
The Clinical Project Manager (CPM) is a key member of the Global Drug Development team at Novartis, responsible for the planning, execution, and reporting of assigned studies in assigned geographies. The CPM serves as the single point of contact and study team lead, ensuring aligned communication with Trial Lead and other Clinical Trial Team (CTT) members, locally with Clinical Research Associates (CRAs), CRA Managers, and other key associates on the execution and progress of their studies in all assigned countries.
Key Responsibilities- Study Planning and Execution: Supports the Study Start-up Manager in developing country/cluster/hub study execution plans and timeline commitments, participates in the recruitment sub-team, and develops innovative solutions for site and patient participation to ensure the delivery of assigned studies on time.
- Initiation and Conduct of Trials: Maintains a strong knowledge of the study protocol, drives the conduct of the study, tracks status, maintains relevant reporting systems, oversees forecasts, progress, and mitigation plans, and ensures recruitment targets are met.
- Local Study Team Activities: Oversees local study team activities to achieve study timelines and quality execution, proposes and implements corrective actions where appropriate, according to Novartis standards and relevant regulations.
- Delivery of Quality Data and Compliance: Conducts or coordinates training for CRAs to support site readiness to recruit and study execution, ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee, and SOP requirements.
The CPM collaborates with the SSO Country Manager, SSO Country Head, SSO Feasibility Manager, SSO Study Start-up Manager, and SSO Site Partnership Manager, and other local stakeholders in the planning, execution, and delivery of their assigned studies in assigned geographies. The CPM represents the voice of the cross-border community in assigned countries in the CTT.
