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.