Regeneron · 9 hours ago
Senior Manager Central Monitoring Data Analysis
United States
Full-time
Hybrid
Senior Level, Lead/Staff
$134K/yr - $219K/yr
8+ years expRegeneron is a leading biotechnology company focused on developing innovative medicines. The Senior Manager, RBQM Data Analyst will oversee centralized monitoring activities for clinical trials, utilizing analytical tools to interpret key risk and performance data. This role involves collaborating with study teams, improving processes, and mentoring junior staff.
BiopharmaBiotechnologyPharmaceutical
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
Qualification
Required
Minimum of a Bachelor's degree
8+ years of relevant clinical related experience
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
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)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2026-01-16
2026-01-16
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