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 teams, sponsors, and cross-functional stakeholders to ensure timely and high-quality deliverables. • Prepare and deliver centralized monitoring reports and lead monitoring review meetings. • Participate in cross-functional risk assessment meetings and contribute to overall risk planning and mitigation strategies. • Develop and enhance monitoring tools, dashboards, and analytical processes to improve risk detection and operational efficiency. • Provide training, mentoring, and guidance to junior team members. • Act as a project lead, development specialist, or a combination of both, depending on project requirements. Qualifications: Education and Experience: • Bachelor's degree in Life Sciences or a related field is mandatory. • Minimum 8+ years of experience in Centralized Monitoring (CM), 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 centralized monitoring tools such as Spotfire, CluePoints, or equivalent 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 Communication Skills: • Demonstrates Accountability, Agility, and Intrapreneurship (AAI) in complex cross-functional and matrix team environments. • Strong written and verbal communication skills in English. • Ability to communicate effectively with internal teams, functional management, sponsors, and clients. • Demonstrates active listening, cultural awareness, and strong stakeholder management skills. • Ability to align business strategies, project objectives, and operational activities. Scientific and Operational Expertise: • 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 understanding of clinical trial complexity involving protocols, patients, sites, countries, and vendors. • Ability to identify, investigate, and mitigate clinical trial risks through data analytics and monitoring oversight. Leadership and Influence: • Demonstrates strong leadership skills in coordinating and overseeing cross-functional teams. • Ability to independently lead projects and manage monitoring activities. • Experience setting priorities, managing timelines, and ensuring high-quality deliverables. • Ability to guide, mentor, and support junior team members. • Strong decision-making and problem-solving skills in complex clinical trial environments. • Ability to influence stakeholders and drive effective collaboration across teams. Knowledge, Skills and Abilities: • Strong knowledge of Centralized Monitoring (CM), Site Monitoring, and Risk-Based Quality Management (RBQM). • Hands-on experience with Spotfire, CluePoints, or similar centralized monitoring tools. • Strong understanding of KRIs, QTLs, risk signal analysis, trend analysis, and anomaly detection. • Ability to perform complex data reviews, root cause analyses, and risk assessments. • Strong analytical, numerical, and problem-solving skills with attention to detail. • Ability to identify trends and potential risks using clinical trial data and electronic study systems. • Comprehensive understanding of clinical trial protocols, centralized monitoring plans, and functional study documentation. • Ability to apply regulatory guidelines, global SOPs, and client requirements. • Strong organizational and project management skills, including planning, prioritization, and workload management. • Ability to independently manage multiple projects and coordinate activities across teams. • Strong stakeholder management and cross-functional collaboration skills. • Ability to maintain confidentiality of clinical trial data and client information. • Proven flexibility, adaptability, and accountability in changing project environments. • Strong computer skills, including proficiency in Microsoft Office (Word, Excel, and PowerPoint). • Ability to learn and effectively utilize clinical trial monitoring and data analytics systems. • Ability to serve as a Subject Matter Expert (SME) and lead cross-functional projects.