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Sr Manager Central Monitoring, Data Analysis

Employer
Regeneron Pharmaceuticals, Inc.
Location
United States
Start date
May 30, 2024

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Discipline
Clinical, Clinical Testing/Monitoring
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

We are seeking a highly motivated 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 includes the following:

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 partners (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 partners 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 collaborators (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.

This role may be for you if:

  • 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
  • Knowledge of 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 Bachelors degree and at least 8-10 years of relevant biotechnology/pharmaceutical industry experience or 6-8 years of experience with an advanced degree. Central Monitoring, site monitoring or data management experience a plus. Minimum 3 years with direct RBQM systems experience.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$129,800.00 - $211,800.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US

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