Senior Data Surveillance Analyst

Parexel; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Parexel, a leading global clinical development partner, is hiring for a Central Monitoring, Data Analysis role in Hyderabad. You will lead centralized monitoring activities for global trials, ensure RBQM configuration and data integrity, and drive improvements with cross-functional teams.

Responsibilities include overseeing RBQM setup, analyzing KRI/KPI data, and developing analyses using R, SQL, SAS, and Python to deliver actionable insights while maintaining regulatory compliance and patient

Qualifications

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

Responsibilities

• Act as a subject matter expert for configuration, implementation, and execution of Central Monitoring RBQM systems across studies.
• Maintain KRI and Quality Tolerance Limit libraries within RBQM platform for standard deployment.
• Coordinate with stakeholders to develop configuration specifications for RBQM in RBQM systems.
• Provide operational expertise, training, and guidance for Central Monitoring RBQM issues.
• Conduct central monitoring reviews, interpreting KRI/KPI data with actionable insights.
• Develop/automate analyses using Python/R/SQL/SAS to support data analytics.
• Participate in standardization improvements of technologies, systems, and training materials.
• Represent Central Monitoring in process improvement initiatives and collaborate cross-functionally.

Skills

RBQM systems

Python

R

SQL

SAS

Data analysis

Regulatory compliance

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree or equivalent

Master's degree in related field (Data Science/Biostatistics/Clinical Research)

Tools

RBQM platforms

CluePoints

Job description

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.

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.