83 applicants

Company

Original Job Post

Regeneron · 2 days ago

Senior Manager, Central Monitoring Data Analyst

United States

Full-time

Hybrid

Senior Level

$130K/yr - $212K/yr

8+ years exp

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BiopharmaBiotechnology

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Develop and author the Central Monitoring Plan

Participate in the study Quality Risk Assessment and Control Tracker (QRACT) development

Conduct and communicate Study-level Central Monitoring Review for assigned studies

Interpret relationships between Key Performance Indicators/metrics and supporting data to assess trends

Review, interpret, and report data to identify centralized monitoring activities and sites requiring intervention

Support study teams in understanding findings and defining follow-up actions

Document output from Central Monitoring Review meetings and track decisions/actions

Lead development of new data review tools and improve existing tools

Define strategies and provide insights for Risk Based Quality Management (RBQM) for Central Monitoring

Act as a subject matter expert for RBQM system configuration and execution

Maintain Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries

Coordinate with partners to develop configuration specifications for Central Monitoring in RBQM system

Provide leadership, training, and guidance for Central Monitoring RBQM system issues

Facilitate Data Transfer Agreements for Central Monitoring RBQM system

Participate in Central Monitoring RBQM system user group

Participate in ongoing improvements in technologies, systems, and processes supporting Central Monitoring and RBQM

Represent Central Monitoring in process improvement initiatives

Assign and delegate tasks to RBQM Data Analyst Manager

Mentor junior Central Monitoring staff

Qualification

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Technical experienceClinical drug developmentICH guidelinesGCP guidelinesBusiness trendsProgramming languagesMathematical conceptsStatistical conceptsData analyticsClinical databasesElectronic data capture systemsQuality control processesAuditing proceduresRBQM systems experienceMicrosoft Office proficiencyProblem solvingCritical thinkingCommunicationInterpersonal skillsCentral MonitoringSite MonitoringData Management

Required

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

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

Minimum 3 years with direct RBQM systems experience

Preferred

Central Monitoring, site monitoring or data management experience

May require 25% travel

Benefits

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Company

Regeneron

Glassdoor

3.9

Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.

Founded in 1988

Tarrytown, New York, USA

10,001+ employees

http://www.regeneron.com

H1B Sponsorship

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2020 (122)