Manager, Central Monitoring/RBQM Programmer - FSP

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2 Locations
Remote
Pharmaceutical
The Role

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Manager, Data Analysis, is responsible for overseeing centralized monitoring activities for global and/or complex clinical trials, ensuring the effective configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) systems. This role involves configuring studies within an RBQM platform, performing recurring data refreshes, troubleshooting errors in execution, and leveraging programming expertise to support advanced data analyses, automation, and reporting.

The Manager will play a critical role in interpreting and presenting Key Risk Indicator (KRI) and Key Performance Indicator (KPI) data, as well as conducting comprehensive reviews of supplemental operational data, trends, and issues. Proficiency in programming languages such as R, SQL, or SAS will be essential for creating custom analyses, automating workflows, and integrating data systems. As an integral member of the Central Monitoring team, the Manager will deliver actionable insights to drive decision-making and optimize trial performance.

Additionally, the Manager will oversee multiple studies within a designated therapy area, lead process improvement initiatives, and contribute to innovation in central monitoring capabilities through collaboration with cross-functional teams and industry partners. This role requires a combination of technical expertise, analytical problem-solving skills, and effective communication to succeed in a dynamic, fast-paced environment.

Job Duties:

  • 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.

Job Requirements:

  • 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.

#LI-LO1

EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

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The Company
HQ: Durham, North Carolina
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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