Senior central monitor

Position SummaryThe Senior Central Monitor will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study KRIs (in collaboration with Functional leads), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings. works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, the Central Monitor may mentor junior colleagues, and may support the development of processes, procedures and other documentation to ensure a high functioning teamEssential functions of the job include but are not limited to: Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's specific needs - including identification of critical data & process, definition of KRIs & QTLs and centralized monitoring approachStudy Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PMCentralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.RBQM Meetings: lead facilitation of monthly RBQM meetings by supporting review of study data, documenting findings, action plans and coordination of data cleaning activities to support study deliverablesData Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studiesReporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediationMentor and Support Junior Colleagues: Act as a mentor to more junior Central Monitors - sharing best practices, lessons learned, etc. to improve team performanceSponsor Engagement and Communications: support discussions with Sponsors around risk management and proactive data cleaningQualificationsMinimum Required:Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experienceMinimum 5 years experience in clinical monitoring, clinical trial management or equivalentWorking knowledge of ICH GCP guidelines and the clinical development processOther RequiredHighly effective oral and written communication skills with the ability to communicate effectively with project team membersExcellent organizational and time management skillsExcellent written and spoken English, including strong grammar and scientific vocabulary skillsAbility to work in a team or independently as requiredStrong understanding of RBQM principles and methodologies.Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess riskProficiency in statistical analysis and data monitoring tools.Detail-oriented with strong analytical and problem-solving skillsDemonstrated experience with integrated risk planning & managementAbility to mentor junior team membersPreferredCRO experience as a Central MonitorSkillsStatistical analysis and data monitoringRisk assessment and mitigationReport writing and presentationCollaboration and teamworkAny data provided as a part of this application will be stored in accordance with our Privacy Policy. 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