Data Surveillance Analyst

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 Data Surveillance Analyst (DSA) to join our team in a India-Hyderabad-Remote capacity. As a Data Surveillance Analyst, you will support clinical research activities that advance new treatments for patients. This position plays a key role in data quality oversight, regulatory compliance, and clinical trial integrity. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through closeout.

Responsibilities include developing and configuring data surveillance systems, reviewing project-specific quality tolerance limits, analyzing scientific and operational data, and presenting findings to project teams. With diverse teams and continuous learning opportunities, the Data Surveillance Analyst can explore career paths and expand skills across clinical research, regulatory affairs, and data management.

Key Responsibilities

Support the development of robust Data Surveillance Plans, including Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis frameworks

Configure and maintain data surveillance technologies (e.g., Clue Points Central Monitoring Platform) and create data import mapping for all data sources

Create and set up standard and bespoke Key Risk Indicators (KRIs) and statistical analysis parameters to drive data-driven decision making

Review relevant data via scoped technologies and additional sources to support project-specific Data Surveillance Plans and Quality Tolerance Limits

Document findings from Data Surveillance activities in the DS Findings Form, Issue Tracking systems, and other appropriate platforms; identify and evaluate data quality trends, outliers, and emergent issues

Actively participate in investigator meetings, external audits, and regulatory inspections; recognize and promptly escalate site and study issues that require immediate action

Maintain comprehensive knowledge of ICH-GCP Guidelines, international and local regulations, Parexel SOPs, and sponsor training requirements; ensure full compliance across all activities

Collaborate with Data Surveillance team members to correlate findings from various sources, compile signals and actions into client-ready reports, and support Central Monitoring documentation

You'll thrive in this role if you bring:

Comprehensive knowledge of RBQM processes and data surveillance methodologies

Experience working in clinical research, healthcare, or a regulated environment with strong data analysis and quality orientation

The ability to collaborate across matrix and global virtual teams and communicate clearly with diverse stakeholders

A patient-focused mindset, strong attention to detail, and proficiency with relevant software (CTMS, EDMS, MS Office, and Parexel-specific technologies)

Excellent interpersonal and communication skills, including presentation abilities, with strong time management and multitasking capabilities

Required Qualifications

Bachelor's degree in medical, biological science, pharmacy, data analytics, or relevant clinical, technology, or business equivalent

2 or more years of relevant medical, clinical, or data management work experience

Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes

Basic SAS programming and/or SQL script writing experience

Strong communication, organization, and problem-solving skills with ability to work independently with minimal supervision

Preferred Qualifications

Experience working within an adaptive monitoring design study

Participation in a Central Monitoring or Data Surveillance process

Familiarity with SDTM domains and data operations concepts

Experience with centralized monitoring and Data Driven 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.

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! 

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