Central Monitoring Operations Manager - FSP

About this role

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

## Summarized Purpose:

Acts as a Subject Matter Expert (SME) and interdepartmental and client liaison for data analytics activities.

• Focuses on developing tools and processes to detect, investigate, diagnose, and mitigate clinical trial issues and risks.
• Leads one or more projects, including setting up functional plans, monitoring tools, and data review cycles.
• Provides expertise in centralized monitoring, site monitoring strategy, risk assessment, and clinical trial oversight.
• Ensures effective risk identification, trend analysis, and signal detection to support trial quality, patient safety, and data integrity.

## Essential Functions and Other Job Information:

• Accountable for **site monitoring strategy and oversight**, including authoring risk assessments and monitoring plans.
• Ensure effective **sponsor oversight, trend analysis, and signal detection** to support trial quality and delivery.
• Provide **site monitoring expertise** to the trial team and lead the implementation of monitoring and oversight approaches.
• Oversee **planning, execution, and issue management** of site monitoring activities across all R/OPUs.
• Ensure compliance with **protocols, ICH-GCP, regulatory requirements**, and maintain inspection readiness.
• Safeguard **patient safety, data integrity, and trial outcomes** through effective monitoring oversight.
• Lead centralized monitoring activities, including the development of study-specific tools, monitoring plans, and data review processes.
• Perform complex data reviews, risk signal analysis, trend analysis, and root cause analysis to identify and mitigate potential risks.
• Monitor **Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Risk-Based Quality Management (RBQM)** activities.
• Manage review timelines, analysis assignments, project deliverables, and support budget management.
• Coordinate with internal te...