15 oct
|
FTARG Fortrea Argentina
|
Buenos Aires
15 oct
FTARG Fortrea Argentina
Buenos Aires
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 escalat 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 Integral 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 devel
📌 Manager, Centralized Monitoring (Buenos Aires)
🏢 FTARG Fortrea Argentina
📍 Buenos Aires