Manager, Centralized Monitoring

About the role

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.

What you'll do

• 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
• 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

What you need

• 10–12 yrs of experience
• SOP writing
• Six Sigma
• Reporting
• Lean
• Process improvement
• Excel
• Any graduate

Good to have

• Clinical research
• GCP
• Performance management
• Reconciliation
• Costing
• PowerPoint