Senior Manager Central Monitoring Data Analysis

Regeneron Pharmaceuticals

2d

About The Position

The Senior Manager, RBQM Data Analyst will be a subject matter expert for Central Monitoring RBQM systems. The Senior Manager, RBQM Data Analyst is accountable for centralized monitoring activities for global and/or complex trials or program level analytical data review of key risk and/or operational performance data and presenting as an integral member of the Clinical Study team. The reviews include interpretation of Key Risk Indicator (KRI) and/or Key Performance Indicator (KPI) data housed in an analytical tool as well as a comprehensive review of supplemental operational data/trends and issues to be interpreted, reported and presented to the study teams. The Senior Manager, RBQM Data Analyst will be responsible for supporting a number of studies within a therapy area. The role will lead, contribute, and drive continued process improvement and innovation activities, and industry collaborations in central monitoring capabilities. A typical day in this role looks like: Central Monitoring Reviews Responsible for development and authoring activities of the Central Monitoring Plan. Participate in the study Quality Risk Assessment and Control Tracker (QRACT) development. Conduct & Communicate Study-level Central Monitoring Review for assigned studies in a given program/therapeutic area using data analysis tools. Interpret the relationships between each Key Performance Indicator/metric and any supporting data to critically assess trends within a site/study. Review, interpret and report data as an integral part of the Clinical Study Team in support of identifying centralized monitoring activities and/or investigator sites potentially requiring sponsor intervention. Support study teams in understanding the impact, criticality and potential root causes of the findings and defining appropriate follow-up actions. Document the output from the Central Monitoring Review meetings and track decisions/actions to closure. Access, review and complete applicable tracking and reporting tools when necessary e.g. CTMS/ODR/etc. Lead development of new data review tools and improve existing data review tools as needed for study level reviews and functional level reviews. RBQM methodology & System SME & RBQM System oversight Define strategies, interpret data, and provide insights for Risk Based Quality Management (RBQM) for Central Monitoring at functional and partnership levels. Act as a subject matter expert for the configuration, implementation, and execution of Central Monitoring RBQM system across studies. Participate in functional oversight of RBQM system vendor(s) in collaboration with cross functional stakeholders (e.g. budgets, timelines, performance metrics, system update releases). Maintain Regeneron Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries within Central Monitoring RBQM system to ensure standard deployment consistency and alignment with regulatory requirements. Coordinate with functional and cross functional stakeholders to develop configuration specifications for Central Monitoring in RBQM system. Provide leadership, operational expertise, training, and guidance as a point of escalation for Central Monitoring issues related to Central Monitoring RBQM system. Facilitate, review, and approve Data Transfer Agreements for Central Monitoring RBQM system in collaboration with cross functional stakeholders (e.g., Data Management). Participate in Central Monitoring RBQM system user group. Continuous Improvement Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials that support Central Monitoring and RBQM. Represent Central Monitoring in process improvement initiatives. Assign and delegate appropriate tasks to RBQM Data Analyst Manager. Mentorship of junior Central Monitoring staff. May require 25% travel.

Requirements

• Technical experience in database, system, and report development
• Analytical problem solving/critical thinking abilities and experience
• Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and regulations
• Effective communication and interpersonal skills; ability to build relationships internally and externally
• Understands current and possible future business trends and information
• Demonstrates writing skills to deliver messages effectively so messages are clearly understood
• Experience with programming languages, including statistical programming language
• Aptitude for mathematical concepts, statistical concepts, and data analytics
• Knowledge and experience with clinical databases, systems, electronic data capture systems, quality control processes, and auditing procedures
• Proficiency in Microsoft Office applications
• a minimum of a Bachelor's degree and 8+ years of relevant clinical related expereince is required.

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 & Communicate Study-level Central Monitoring Review for assigned studies in a given program/therapeutic area using data analysis tools.
• Interpret the relationships between each Key Performance Indicator/metric and any supporting data to critically assess trends within a site/study.
• Review, interpret and report data as an integral part of the Clinical Study Team in support of identifying centralized monitoring activities and/or investigator sites potentially requiring sponsor intervention.
• Support study teams in understanding the impact, criticality and potential root causes of the findings and defining appropriate follow-up actions.
• Document the output from the Central Monitoring Review meetings and track decisions/actions to closure.
• Access, review and complete applicable tracking and reporting tools when necessary e.g. CTMS/ODR/etc.
• Lead development of new data review tools and improve existing data review tools as needed for study level reviews and functional level reviews.
• Define strategies, interpret data, and provide insights for Risk Based Quality Management (RBQM) for Central Monitoring at functional and partnership levels.
• Act as a subject matter expert for the configuration, implementation, and execution of Central Monitoring RBQM system across studies.
• Participate in functional oversight of RBQM system vendor(s) in collaboration with cross functional stakeholders (e.g. budgets, timelines, performance metrics, system update releases).
• Maintain Regeneron Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries within Central Monitoring RBQM system to ensure standard deployment consistency and alignment with regulatory requirements.
• Coordinate with functional and cross functional stakeholders to develop configuration specifications for Central Monitoring in RBQM system.
• Provide leadership, operational expertise, training, and guidance as a point of escalation for Central Monitoring issues related to Central Monitoring RBQM system.
• Facilitate, review, and approve Data Transfer Agreements for Central Monitoring RBQM system in collaboration with cross functional stakeholders (e.g., Data Management).
• Participate in Central Monitoring RBQM system user group.
• Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials that support Central Monitoring and RBQM.
• Represent Central Monitoring in process improvement initiatives.
• Assign and delegate appropriate tasks to RBQM Data Analyst Manager.
• Mentorship of junior Central Monitoring staff.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees