Senior Data Surveillance Analyst

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were 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 22000 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. Youll 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. Youll 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.

Youll 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

• Bachelors 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

• Masters 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 doesnt sound like the next step in your career but perhaps you know of someone whod 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.