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 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 monito

📌 Manager, Centralized Monitoring (Santiago) (Región Metropolitana)
🏢 Fortrea
📍 Región Metropolitana