Manager, Centralized Monitoring

Job Overview

• Reviews trip reports, proactively identifies risks and communicate any trends, outstanding issues, safety concerns to the study team.
• Responsible for the execution of key Central monitoring activities (Site, region & study level review as applicable) and collaborates with the study team to execute Central Monitoring activities and comply with client expectations and notify any changes/risk and elevate as appropriate.
• Critical role in ensuring full implementation of the risk plan and recommending appropriate changes to ongoing monitoring.
• Provides people leadership for a team of 8-20, encompassing performance management, coaching, resource planning and hiring, and continuous process improvement to ensure high-quality delivery.

Summary Of Responsibilities

• Review monitoring trip reports to ensure quality, compliance, and implementation of best practices; collaborate with project teams to revise project plans as needed.
• Proactively identify risks, trends, protocol deviations, safety concerns, and outstanding issues from trip reports; communicate findings to study teams and ensure issues are tracked through resolution.
• Act as a liaison between CRAs, CTLs, and Project Managers to support timely issue escalation and resolution.
• Train and mentor CRAs, IHCRAs, and new CMLs on trip report writing, monitoring activities, ICH‑GCP, SOPs, and local work instructions.
• Develop and maintain trip report templates and guidelines.
• Perform document review activities including eTMF reconciliation, protocol deviation review and trending, issue management, and study analytics.
• Serve as the primary point of contact for communication with Global CTLs and Project Managers.
• Act as study lead for centralized monitoring and oversee site‑, regional‑, and study‑level central monitoring activities across multiple studies.
• Provide oversight and support to central monitoring teams to ensure accurate tracking, analysis, and reporting of study risks and monitoring status.
• Support 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).
• Manage a portfolio of studies for assigned customers and act as a key customer point of contact.
• Oversee tracking, interpretation, and application of data to proactively manage risk and recommend changes to monitoring strategies and intervention levels.
• Support development of Critical Data and Critical Process Definitions.
• Contribute to study specific XRR dashboard development, including design and refinement of dashboards and visualizations aligned with study data sources (e.g., EDC, CTMS).
• Draft, maintain, and update Central Monitoring Plans, Configuration Plans, and related controlled documents in alignment with evolving risk profiles, standard risk libraries, and study changes.
• Configure central monitoring tools, study‑specific risk factors, trigger thresholds, and parameters; perform user acceptance testing (UAT).
• Review, approve, and appropriately elevate changes to monitoring levels in compliance with applicable plans and sponsor requirements.
• Plan, lead, conduct, and follow up on central monitoring activities; perform ongoing dashboard and analytics reviews and provide data‑driven recommendations.
• Coach and mentor internal and external project teams to enhance centralized and risk‑based monitoring capability.
• Support PMO activities including preparation of the Risk Management Register, Study Risk Impact Reports, and site risk weighting.
• Contribute to central monitoring proposal development, bid defence materials, costing reviews, and sponsor presentations.
• Oversee Project Quality and Risk Reports to ensure compliance and client satisfaction.
• Provide technical leadership to study teams to ensure effective implementation of monitoring processes, tools, and risk‑based approaches.
• Contribute to SOP development, process mapping, and continuous improvement initiatives using LEAN and Six Sigma methodologies.
• Identify, evaluate, and propose process, system, and tool improvements with appropriate justification.
• Manage assigned projects under the direction of a Project Manager or Director and ensure timely and effective communication with clinical operations teams.
• Ensure all monitoring activities comply with Fortrea SOPs, ICH‑GCP, and regulatory requirements.
• Follow established issue escalation and corrective action processes and proactively identify opportunities for improvement.
• Complete required training within defined timelines and support development and maintenance of training materials.
• Promote effective cross‑func