Central Monitoring Operations Manager – FSP

• Act as a Subject Matter Expert and interdepartmental and client liaison for data analytics activities
• Develop tools and processes to detect, investigate, diagnose, and mitigate clinical trial issues and risks
• Lead projects by setting up functional plans, monitoring tools, and data review cycles
• Provide expertise in centralized monitoring, site monitoring strategy, risk assessment, and clinical trial oversight
• Author site monitoring risk assessments and monitoring plans
• Lead 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 inspection readiness
• Safeguard patient safety, data integrity, and trial outcomes through monitoring oversight
• Lead centralized monitoring activities, including study-specific tools, monitoring plans, and data review processes
• Perform complex data reviews, risk signal analysis, trend analysis, anomaly detection, and root cause analysis
• Monitor KRIs, QTLs, and RBQM activities
• Manage review timelines, analysis assignments, project deliverables, and budget support
• Coordinate with internal teams, sponsors, and cross-functional stakeholders
• Prepare and deliver centralized monitoring reports and lead monitoring review meetings
• Participate in cross-functional risk assessment meetings and contribute to risk planning and mitigation strategies
• Develop and enhance monitoring tools, dashboards, and analytical processes
• Provide training, mentoring, and guidance to junior team members
• Act as a project lead, development specialist, or both depending on project requirements

• Bachelor's degree in Life Sciences or a related field is mandatory
• Minimum 8+ years of experience in Centralized Monitoring, clinical monitoring, or related clinical trial activities
• Hands-on experience in site monitoring strategy and oversight, including developing risk assessments and monitoring plans
• Hands-on experience with Spotfire, CluePoints, or equivalent centralized monitoring platforms
• Strong experience in Risk-Based Quality Management (RBQM), Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs)
• Practical experience in risk signal analysis, trend analysis, anomaly detection, and root cause analysis
• Experience in clinical trial monitoring, site management, data management, biostatistics, or related clinical research activities
• Experience leading centralized monitoring activities, managing review cycles, and coordinating with cross-functional teams
• Strong understanding of clinical trial protocols, ICH-GCP guidelines, regulatory requirements, and global SOPs
• Experience in sponsor oversight, clinical trial risk assessment, and risk mitigation
• Experience managing complex clinical trials involving multiple sites, countries, vendors, and stakeholders
• Equivalent professional education and directly relevant experience may be considered where applicable
• Strong written and verbal communication skills in English
• Strong scientific, therapeutic, and operational knowledge of clinical trial planning and execution
• Comprehensive understanding of site monitoring, centralized monitoring, and site management processes
• Experience implementing risk-based monitoring strategies across clinical studies
• Ability to interpret clinical trial protocols, monitoring plans, and study documentation
• Strong leadership, decision-making, problem-solving, organizational, project management, and stakeholder management skills
• Strong computer skills, including proficiency in Microsoft Office (Word, Excel, and PowerPoint)
• Ability to maintain confidentiality of clinical trial data and client information
• Ability to serve as a Subject Matter Expert and lead cross-functional projects

• Fully remote work arrangement
• Standard Monday–Friday work schedule