The Senior Manager, Central Monitoring RBQM Data Analysis will be a subject matter expert for Central Monitoring RBQM systems.
In this role, a typical day might include:
Accountability 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. You will be responsible for supporting a number of studies within a therapy area. This role will lead, contribute, and drive continued process improvement and innovation activities, and industry collaborations in central monitoring capabilities.
This role might be for you if have experience with:
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 eg. 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.
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.
To be considered for this opportunity, you must have the following:
Minimum Bachelors degree and at least 8-10 years of relevant biotechnology/pharmaceutical industry experience or 6-8 years of experience with an advanced degree.
Minimum 3 years with direct RBQM systems experience.
Central Monitoring, site monitoring or data management experience a plus. Minimum 3 years with direct RBQM systems 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
Demonstrates the ability to deliver messages effectively, both written and verbal, so that messages are clearly understood
Understands current and possible future business trends and information
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
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$126,600.00 - $206,600.00