Job Description Summary Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards.
May lead specific aspects of global clinical trial(s).
Core member of the Clinical Trial Team, contributes to operational excellence through process improvement and knowledge sharing.
Job Description Major accountabilities: Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards.Ensures proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.Reports technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
Distribution of marketing samples (where applicable).Key performance indicators: Timely, efficient and quality execution of assigned trials and trial-related activities within budget, and in compliance with quality standards.Proactive operational planning with effective contingency and risk mitigation plans.Adherence to Novartis policy and guidelines and external regulations.Minimum Requirements: Work Experience: Financial Management.Project Management.Collaborating across boundaries.Operations Management and Execution.Skills: Auditing.Clinical Monitoring.Clinical Research.Clinical Study Reports.Clinical Trial Management Systems.Clinical Trials.Data Auditing.Data Management.Health Sciences.Lifesciences.Project Management.Project Planning.Vendor Management.Languages: English.Skills Desired: Auditing.Clinical Monitoring.Clinical Research.Clinical Study Reports.Clinical Trial Management Systems.Clinical Trials.Data Auditing.Data Management.Health Sciences.Lifesciences.Project Planning.Vendor Management.Waterfall Model.
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