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Parexel · 2 hours ago

Manager, Central Monitoring, Data Analysis - FSP

United States

Full-time

Remote

Mid, Senior Level

4+ years exp

Parexel is a global leader in clinical development solutions dedicated to improving the world's health. The Manager, Data Analysis, is responsible for overseeing centralized monitoring activities for clinical trials, ensuring effective execution of Risk-Based Quality Management (RBQM) systems, and delivering actionable insights to optimize trial performance.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Act as a subject matter expert for the configuration, implementation, and execution of Central Monitoring RBQM system across studies

Maintain 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 operational expertise, training, and guidance as a point of escalation for Central Monitoring issues related to Central Monitoring RBQM system

Conduct central monitoring reviews in support of study central monitor

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

May require 25% travel

Qualification

RBQM systems experienceProgramming languages RProgramming languages SQLProgramming languages SASData analysisDatabase designClinical drug developmentAnalytical problem-solvingProcess improvementMicrosoft Office proficiencyCommunication skillsTeam collaboration

Required

At least 4 years of relevant biotechnology/pharmaceutical industry experience

Central Monitoring, site monitoring or data management experience a plus

Minimum 2 years with direct RBQM systems experience

Technical expertise in database design, system configuration, and report development, with experience in managing Risk-Based Quality Management (RBQM) systems or similar platforms

Proficiency in programming languages such as Python, R, SQL, or SAS, with the ability to develop scripts for data analysis, automation, and system integration

Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements

Aptitude for mathematical concepts, statistical methodologies, and data analytics, with a focus on interpreting Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs)

Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures

Proficiency in Microsoft Office applications, with advanced skills in Excel for data manipulation and reporting

Preferred

Experience using CluePoints or similar centralized monitoring and risk-based quality management solutions

Company

Parexel

Glassdoor3.9

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees

http://www.parexel.com

H1B Sponsorship

Parexel 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 (33)

2024 (46)

2023 (41)

2022 (51)

2021 (54)

2020 (33)