Monitoring Data Analysis

Overview

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.

• 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.

• 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.

• May require 25% travel.

• Proficiency and experience with Cluepoints or similar RQBM system for Central Monitoring

• 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

In order to be considered qualified for this role
, a minimum of a Bachelor's degree and 8+ years of relevant clinical related expereince is required.

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