# Central Monitoring Lead **Company**: Fortrea **Work arrangement**: hybrid **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Mexico-City/Manager--Centralized-Monitoring_266056?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_b3f90c19-14c ## Description We are seeking a Central Monitoring Lead to oversee the execution of key central monitoring activities across multiple studies. The successful candidate will be responsible for reviewing trip reports, identifying risks and trends, and communicating findings to study teams. They will also provide people leadership for a team of 8-20, encompassing performance management, coaching, resource planning, and hiring. Key responsibilities include: - Reviewing monitoring trip reports to ensure quality, compliance, and implementation of best practices - Proactively identifying risks, trends, protocol deviations, safety concerns, and outstanding issues from trip reports - Acting as a liaison between CRAs, CTLs, and Project Managers to support timely issue escalation and resolution - Training and mentoring CRAs, IHCRAs, and new CMLs on trip report writing, monitoring activities, ICH-GCP, SOPs, and local work instructions - Developing and maintaining trip report templates and guidelines - Performing document review activities, including eTMF reconciliation, protocol deviation review and trending, issue management, and study analytics - Serving as the primary point of contact for communication with Global CTLs and Project Managers - Overseeing site-, regional-, and study-level central monitoring activities across multiple studies - Providing oversight and support to central monitoring teams to ensure accurate tracking, analysis, and reporting of study risks and monitoring status - Supporting development of detailed study risk assessments, including risk factor definitions, trigger thresholds, SDV strategies, mitigation plans, and contributions to the Risk Assessment and Categorization Tool (RACT) - Managing a portfolio of studies for assigned customers and acting as a key customer point of contact - Overseeing tracking, interpretation, and application of data to proactively manage risk and recommend changes to monitoring strategies and intervention levels - Supporting development of Critical Data and Critical Process Definitions - Contributing to study-specific XRR dashboard development, including design and refinement of dashboards and visualizations aligned with study data sources - Drafting, maintaining, and updating Central Monitoring Plans, Configuration Plans, and related controlled documents in alignment with evolving risk profiles, standard risk libraries, and study changes - Configuring central monitoring tools, study-specific risk factors, trigger thresholds, and parameters; performing user acceptance testing (UAT) - Reviewing, approving, and appropriately escalating changes to monitoring levels in compliance with applicable plans and sponsor requirements - Planning, leading, conducting, and following up on central monitoring activities; performing ongoing dashboard and analytics reviews and providing data-driven recommendations - Coaching and mentoring internal and external project teams to enhance centralized and risk-based monitoring capability - Supporting PMO activities, including preparation of the Risk Management Register, Study Risk Impact Reports, and site risk weighting - Contributing to central monitoring proposal development, bid defense materials, costing reviews, and sponsor presentations - Overseeing Project Quality and Risk Reports to ensure compliance and client satisfaction - Providing technical leadership to study teams to ensure effective implementation of monitoring processes, tools, and risk-based approaches - Contributing to SOP development, process mapping, and continuous improvement initiatives using LEAN and Six Sigma methodologies - Identifying, evaluating, and proposing process, system, and tool improvements with appropriate justification - Managing assigned projects under the direction of a Project Manager or Director and ensuring timely and effective communication with clinical operations teams - Ensuring all monitoring activities comply with Fortrea SOPs, ICH-GCP, and regulatory requirements - Following established issue escalation and corrective action processes and proactively identifying opportunities for improvement - Completing required training within defined timelines and supporting development and maintenance of training materials - Promoting effective cross-functional collaboration among internal and external stakeholders - Providing direct people management for assigned staff (8-20 direct reports), including supervision, performance management, coaching, and resolution of performance issues - Measuring and monitoring performance indicators; identifying training needs and supporting training and development efforts - Providing GCP and quality oversight by ensuring required training is completed, understood, and implemented; identifying and resolving GCP/quality issues through appropriate corrective actions - Holding staff accountable for quality, compliance with Fortrea and client SOPs, and adherence to deliverable timelines; supporting onboarding and role-specific training - Ensuring site monitoring activities comply with Fortrea SOPs, ICH-GCP, and applicable work instructions; supporting inspection readiness and regulatory authority inspections - Communicating workload status for metric reporting; reviewing billable hours, utilization, and productivity against budgets; escalating outliers and supporting mitigation - Supporting resource planning, recruitment (screening/interviewing), expense management, and financial authority per approval matrix - Promoting standardized processes and tools; participating in process improvement initiatives to enhance efficiency and productivity ## Skills ### Required - ICH-GCP - MS Office Suite - risk management - clinical research - centralized monitoring ### Nice to have - Fortrea SOPs - LEAN - Six Sigma --- Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Mexico-City/Manager--Centralized-Monitoring_266056?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)