Central Monitoring Data Analysis

Role Summary

The Senior Manager, RBQM Data Analyst is a subject matter expert for Central Monitoring RBQM systems and is accountable for centralized monitoring activities for global and/or complex trials or program-level analytical data review of key risk and operational performance data. The role involves interpreting KRIs and KPIs, reviewing supplemental operational data, and presenting findings to the Clinical Study Team. This position leads and contributes to process improvements and innovation in central monitoring capabilities and supports multiple studies within a therapy area.

Responsibilities

• Responsible for development and authoring activities of the Central Monitoring Plan.
• Participate in the study Quality Risk Assessment and Control Tracker (QRACT) development.
• Conduct and communicate Study-level Central Monitoring Reviews for assigned studies using data analysis tools.
• Interpret relationships between KPIs/metrics and supporting data to assess trends within a site/study.
• Review, interpret, and report data as part of the Clinical Study Team to identify centralized monitoring activities and sites requiring sponsor intervention.
• Support study teams in understanding impact, criticality, and root causes of findings and define follow-up actions.
• Document outputs from Central Monitoring Review meetings and track decisions/actions to closure.
• Access, review, and complete applicable tracking and reporting tools (e.g., CTMS/ODR).
• Lead development of new data review tools and improve existing tools for study-level and functional-level reviews.
• Define strategies, interpret data, and provide RBQM insights for Central Monitoring at functional and partnership levels.
• Act as a subject matter expert for configuration, implementation, and execution of Central Monitoring RBQM system across studies.
• Participate in oversight of RBQM system vendors with cross-functional stakeholders.
• Maintain Central Monitoring KRIs and Quality Tolerance Limit Libraries to ensure standard deployment and regulatory alignment.
• Coordinate with stakeholders to develop configuration specifications for Central Monitoring in the RBQM system.
• Provide leadership, training, and guidance for Central Monitoring issues related to RBQM.
• Facilitate, review, and approve Data Transfer Agreements for Central Monitoring RBQM system with cross-functional partners.
• Participate in Central Monitoring RBQM system user group.
• Participate in ongoing improvements to technologies, systems, processes, and training materials supporting Central Monitoring and RBQM.
• Represent Central Monitoring in process improvement initiatives.
• Assign and delegate appropriate tasks to RBQM Data Analyst Manager.
• Mentor junior Central Monitoring staff.
• May require up to 25% travel.

Qualifications

• Required: Bachelor's degree and 8+ years of relevant clinical research experience.
• Preferred: Proficiency with Cluepoints or similar RBQM systems for Central Monitoring.
• Preferred: Technical experience in database, system, and report development.
• Preferred: Analytical problem-solving/critical-thinking abilities and experience.
• Preferred: Working knowledge of clinical drug development, ICH, GCP guidelines, and regulations.
• Preferred: Effective communication and interpersonal skills; ability to build internal and external relationships.
• Preferred: Understanding of current and potential future business trends and information.
• Preferred: Strong writing skills to clearly convey messages.
• Preferred: Experience with programming languages, including statistical programming language.
• Preferred: Aptitude for mathematical and statistical concepts and data analytics.
• Preferred: Knowledge of clinical databases, EDC systems, QA processes, and auditing procedures.
• Preferred: Proficiency in Microsoft Office applications.

Skills

• Analytical problem solving and critical thinking
• Data analysis and interpretation of KRIs/KPIs
• Central Monitoring and RBQM system configuration and oversight
• Technical data tools development and tool improvement
• Cross-functional collaboration and stakeholder management
• Effective written and verbal communication

Education

• Bachelor's degree (required)

Additional Requirements

• May require up to 25% travel.