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.
• Robust 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.

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