Site Monitoring Lead

Site Monitoring Lead Overview

• The Site Monitoring Lead oversees monitoring strategies and site activities for clinical studies, ensuring compliance with ICH-GCP and SOPs.
• Collaborates with the Lead Study Manager to develop and implement monitoring plans and tools for effective study execution.
• Acts as the primary contact for study-specific queries from internal and external monitoring teams.
• Provides training and guidance to Site Monitors, ensuring consistent practices across the study.
• Supports audit and inspection activities, contributing to risk management and corrective action plans.
• Conducts monitoring visits and oversight activities to ensure adherence to study protocols and regulatory requirements.
• Analyzes monitoring metrics and data to identify performance trends and implement improvements.
• Maintains strong knowledge of GCP/ICH guidelines and adapts to country-specific regulatory requirements.
• Promotes a high-quality and compliance-focused approach within the monitoring team.

Site Monitoring Lead Key Responsibilities & Duties

• Manage site monitoring activities, ensuring compliance with protocols, SOPs, and regulatory guidelines.
• Develop and maintain monitoring plans, tools, and trackers for study-specific needs.
• Provide training and support to Site Monitors, facilitating study-specific training plans and meetings.
• Conduct monitoring visits, oversight visits, and training sessions as required by study needs.
• Support audit and inspection activities, contributing to risk management and corrective actions.
• Analyze site performance data and implement corrective actions to address issues effectively.
• Ensure adherence to Good Documentation Practices and regulatory requirements.
• Collaborate with cross-functional teams to ensure seamless study execution and monitoring oversight.
• Maintain effective communication with internal and external stakeholders to address study-specific queries.

Site Monitoring Lead Job Requirements

• Bachelor’s degree in health or medical sciences or equivalent required.
• Minimum of 3 years of direct site monitoring experience in biopharmaceutical or CRO settings.
• Experience in managing site monitors and global teams preferred.
• Knowledge of GCP/ICH guidelines and country-specific regulatory requirements essential.
• Proficient in IT applications, including MS Office and clinical IT tools.
• Strong analytical skills to assess site performance and implement corrective actions.
• Ability to travel up to 25% and possess a valid driver’s license.
• Demonstrated ability to work independently and manage multiple tasks effectively.
• Excellent communication skills and aptitude for conflict resolution in a matrix environment.