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 escalate 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 escalate 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…