Senior Clinical Data Engineer

Parexel

India

On-site

INR 2,000,000 - 3,500,000

Full time

4 days ago
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Job summary

Parexel is seeking a Senior Clinical Data Engineer to design and implement data management solutions supporting efficient clinical trial operations and regulatory compliance.

You will manage data ingestion, quality assurance, and reporting infrastructure, collaborating with project managers, biostatisticians, and regulatory specialists to deliver first-time-quality data solutions and robust data governance.

Qualifications

  • Advanced proficiency in SAS, SQL or R for complex data solutions.
  • Experience leading virtual teams across multiple time zones.
  • Deep knowledge of clinical trial data management and regulatory practice.
  • Ability to communicate complex concepts to diverse stakeholders.

Responsibilities

  • Lead design and programming for data management solutions and data transfer.
  • Develop import procedures for data ingestion and ensure integration of external sources.
  • Create reconciliation checks and validation protocols across systems.
  • Design offline listings and reports to enable data-driven decisions.
  • Aggregate data from multiple sources and handle missing values with precision.
  • Review outputs to identify trends and opportunities for improvement.
  • Ensure first-time quality and regulatory compliance (ICH-GCP, 21 CFR Part 11).
  • Lead programming teams to deliver on time and manage scope changes.
  • Maintain documentation, data standards and quality processes.

Skills

SAS
SQL
R
Leadership
Mentoring
Data management
ICH-GCP

Tools

Workbench

Job description

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(R).

About the Role

We are seeking a Senior Clinical Data Engineer to join our team. As a Senior Clinical Data Engineer, you will drive the strategic design and implementation of data management solutions that enable efficient clinical trial operations and regulatory compliance. This position plays a critical role in managing data ingestion, quality assurance, and reporting infrastructure that supports study execution and patient safety. You'll collaborate with cross-functional teams including project managers, biostatisticians, and regulatory specialists to deliver first-time-quality data solutions.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through leading technical innovation, mentoring emerging talent, and establishing best practices in clinical data management. With diverse teams and continuous learning opportunities, the Senior Clinical Data Engineer can explore career paths and expand skills across clinical research, data engineering, and regulatory science.

Key Responsibilities
  • Lead the design, implementation, and management of Data Receipt Agreements with vendors and coordinate with cross-functional teams to establish efficient data transfer protocols
  • Program and establish import procedures for data ingestion using SAS, SQL, R, or alternative technologies such as Workbench, ensuring seamless integration of external data sources
  • Develop and execute comprehensive reconciliation checks and validation protocols to ensure accurate and complete data transfer across all systems
  • Design and program offline listings and custom reports that provide actionable insights to study teams and clients, enabling data-driven decision making
  • Aggregate and manage data across multiple sources, handling missing values, raw data files, data structures, and complex programming challenges with precision and accountability
  • Review and analyze data outputs to identify patterns, anomalies, and opportunities for improvement, providing strategic insights to enhance study quality and efficiency
  • Maintain accountability for first-time quality on all deliverables, ensuring compliance with SOPs, regulatory guidelines, and industry standards including ICH-GCP and 21 CFR Part 11
  • Lead and coordinate programming teams to successful project completion within established timelines and budgets, while monitoring resourcing and managing scope changes
  • Manage the deployment and optimization of data management technologies including SAS, Workbench, R, and other systems used for creating offline listings and data solutions
  • Develop, implement, and maintain technical documentation, data standards, and quality processes that ensure traceability, regulatory compliance, and operational efficiency
  • Mentor and provide technical guidance to team members and project teams, fostering a culture of continuous improvement and technical excellence
  • Participate in business development activities including bid defense meetings, contributing technical expertise to support new business opportunities
You’ll thrive in this role if you bring:
  • Advanced technical proficiency in at least one programming language (SAS, SQL, or R) with demonstrated ability to design and implement complex data solutions
  • Strong leadership and mentoring capabilities with the ability to motivate and guide virtual teams across multiple time zones and cultures
  • Extensive experience working in clinical research or regulated environments with deep knowledge of clinical trial processes and data management best practices
  • Excellent communication and interpersonal skills with the ability to translate technical concepts for diverse stakeholders and build strong
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