Site Monitoring Lead

Job Title: Site Monitoring Lead Job Location: Durham, North Carolina, United States of America Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Job Overview The Site Management Lead (SML) is a senior clinical trial professional and key member of the client's global Clinical Trial Team, assigned to one or more trials. Operating at trial leadership level in complex international matrix environments, the SML owns and drives monitoring strategy planning and implementation at trial level, and risk and issue management for all Site Monitoring and Oversight activities. This includes authoring and maintaining monitoring and risk management plans, ensuring sponsor oversight, analyzing trends and risk signals, and collaborating with vendor functions and stakeholders to enable accurate planning and efficient trial delivery. A strong risk-based quality management (RBQM) and data-driven mindset is essential. The SML provides Site Monitoring expertise, consultation and training to the Trial Team (e.g., CRAs and CT Managers) and leads implementation of the Site Monitoring and Oversight approach within the overall clinical trial quality management framework. The SML contributes to the successful delivery of assigned global trials across all R/OPUs in line with defined milestones and key performance indicators. The role requires comprehensive end-to-end knowledge of global clinical trials from start-up through close-out, including the development of monitoring strategies and use of centralized monitoring techniques and data analytics. The SML oversees Site Monitoring activities to protect trial participants, ensure reliable trial results and compliance with the study protocol, sponsor obligations, ICH-GCP and applicable regulations, and maintain inspection readiness. Main Accountabilities: Trial Preparation: Plan trial monitoring strategy and quality and risk monitoring/mitigation. Deliver Risk-based Site Monitoring approach and training for the trial. Accountable for the development of the operational Site Monitoring & Oversight and Integrated Risk Management plans. Develop and provide appropriate training of trial monitoring topics to Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA). Participate in development of trial level documents. Behave as expert and consultant on Site management and monitoring and risk identification and issue management topics. Integrate patient/site level feedback to the documents ensuring...

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