Senior Data Surveillance Analyst

Posted Yesterday
Be an Early Applicant
2 Locations
In-Office
Senior level
Pharmaceutical
The Role
Leads centralized monitoring and risk-based quality management activities for global clinical trials. Configures RBQM systems, maintains risk indicator libraries, reviews KRI and KPI data, develops analyses and automated workflows using programming languages, troubleshoots data issues, supports regulatory compliance, trains stakeholders, and drives process improvements across clinical research operations.
Summary Generated by Built In

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.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.

About the Role

We are seeking a Central Monitoring, Data Analysis to join our team. As a Central Monitoring, Data Analysis, you will lead centralized monitoring activities for global and complex clinical trials, ensuring the effective configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) systems. This position plays a critical role in study execution, data accuracy, regulatory compliance, and driving innovation in clinical trial monitoring. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through closeout.

Responsibilities include overseeing RBQM system configuration and execution, interpreting Key Risk Indicator (KRI) and Key Performance Indicator (KPI) data, developing advanced data analyses using programming expertise, and leading process improvement initiatives. You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through advancing patient safety, optimizing trial performance, and delivering actionable insights. With diverse teams and continuous learning opportunities, the Central Monitoring, Data Analysis can explore career paths and expand skills across clinical research and data analytics.


Key Responsibilities

  • Act as a subject matter expert for the configuration, implementation, and execution of Central Monitoring RBQM systems across studies.
  • Maintain Key Risk Indicator and Quality Tolerance Limit libraries within the RBQM platform 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 systems.
  • Provide operational expertise, training, and guidance as a point of escalation for Central Monitoring issues related to RBQM systems.
  • Conduct central monitoring reviews in support of study central monitors, interpreting and presenting KRI and KPI data with actionable insights.
  • Leverage programming expertise in languages such as R, SQL, or SAS to develop custom analyses, automate workflows, and integrate data systems.
  • 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 and contribute to innovation in central monitoring capabilities through collaboration with cross-functional teams.

 

You'll thrive in this role if you bring:

  • Technical expertise in database design, system configuration, and report development with experience managing 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.
  • Strong analytical problem-solving and critical thinking abilities, with experience troubleshooting data refreshes and resolving execution errors in analytical systems.
  • Experience working in clinical research, healthcare, or a regulated environment.
  • The ability to collaborate across teams and communicate clearly, with effective interpersonal skills.
  • A patient-focused mindset and strong attention to detail.
  • Comfort working with RBQM platforms, electronic data capture systems, and clinical databases.

 

Required Qualifications

  • Bachelor's Degree or equivalent experience in a related field.
  • At least 4 years of relevant biotechnology or pharmaceutical industry experience.
  • Minimum 2 years of direct experience with RBQM systems or similar centralized monitoring platforms.
  • Knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
  • Advanced proficiency in Microsoft Excel for data manipulation and reporting.

 

Preferred Qualifications

  • Master's Degree in a related field such as Data Science, Biostatistics, or Clinical Research.
  • Experience with CluePoints or similar centralized monitoring and risk-based quality management solutions.
  • Experience in site monitoring, data management, or clinical operations.
  • Demonstrated ability to identify and interpret business trends and apply them to centralized monitoring practices.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!


We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

Skills Required

  • Bachelor's degree or equivalent experience in a related field
  • At least 4 years of relevant biotechnology or pharmaceutical industry experience
  • Minimum 2 years of direct experience with RBQM systems or similar centralized monitoring platforms
  • Knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes
  • Advanced proficiency in Microsoft Excel for data manipulation and reporting
  • Master's degree in a related field such as Data Science, Biostatistics, or Clinical Research
  • Experience with CluePoints or similar centralized monitoring and risk-based quality management solutions
  • Experience in site monitoring, data management, or clinical operations
  • Ability to identify and interpret business trends and apply them to centralized monitoring practices

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: Raleigh, NC
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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