Sso Clinical Project Manager - Argentina
Novartis
100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have!
The 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, within the country/cluster/hub, for the assigned studies. The CPM is responsible for assuring aligned communication with Trial Lead and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies. The CPM collaborates with various managers in the planning, execution, and delivery of their assigned studies.
Your responsibilities include, but are not limited to:
1. Study & Site Operations strategy: Supports SSO Study Start-up Manager in the development of country/cluster/hub study execution plans and timeline commitments. Participates in the recruitment sub-team and supports the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time. Proactively identifies risks and opportunities for the assigned studies and develops respective mitigation plans.
2. Initiation and conduct of trials: Supports the study feasibility by providing input to the study protocol and operational aspects of the study. Maintains a strong knowledge of the study protocol to answer standard operational questions. Drives the conduct of the study to ensure all operational aspects are on track.
3. Recruitment targets: Ensures recruitment targets are met and reviews enrolment at the site level. Responsible for setting up contingency plans to achieve targets in accordance with the trial execution plan.
4. Oversight of data management: Maintains oversight of country/cluster/hub level data management activities, proactively identifying data entry issues and coordinating study handover processes.
5. Delivery of quality data: Conducts or coordinates training for CRAs to support site readiness and ensures adherence to clinical data standards. Evaluates potential challenges/risks within the protocol and develops risk management plans.
6. Budget and productivity: Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study conduct.
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