Senior Clinical Data Engineer

Parexel International; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Parexel is seeking a Senior Clinical Data Engineer to drive the design and implementation of data management solutions that support efficient clinical trial operations and regulatory compliance. You will collaborate with project managers, biostatisticians, and regulatory specialists to deliver first-time-quality data solutions.

In this fast-paced role, you will mentor team members, establish best practices in clinical data management, and contribute to data automation and reporting across

Qualifications

• Bachelor's degree in a relevant science discipline or equivalent work experience.
• Minimum 5+ years of experience in clinical research, data management, or a related field.
• Proficiency in at least one programming language (SAS, SQL, or R).
• Hands-on experience with at least two clinical data management systems (such as SAS, Workbench, or Elluminate).
• Strong knowledge of ICH-GCP, regulatory requirements, SOPs, and 21 CFR Part 11.
• Leadership experience mentoring team members and managing technical projects.
• Excellent written and oral communication skills in English.

Responsibilities

• Lead the design, implementation, and management of Data Management solutions and coordinate cross-functional teams.
• Program and establish data ingestion procedures using SAS, SQL, or R for data sources.
• Develop and execute reconciliation checks and validation protocols for data transfer.
• Design offline listings and custom reports for data-driven decision making.
• Aggregate and manage data across multiple sources with data quality and regulatory compliance.
• Mentor programming teams and ensure first-time quality on deliverables.
• Participate in bid defense meetings, contributing technical expertise for new business.

Skills

SAS/SQL/R

Leadership

Clinical Research

Communication

Problem Solving

Data Management Systems

Analytical Thinking

Education

Bachelor's degree in science

Tools

SAS

Workbench

Elluminate

R

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(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 working relationships
• Demonstrated commitment to first-time quality, methodical problem-solving, and continuous process improvement in complex technical environments
• Comfort working with multiple data management systems and technologies, with the ability to quickly master new tools and adapt to evolving technical landscapes
• Strong analytical and strategic thinking skills with the ability to identify opportunities for efficiency improvements and innovation in clinical trial operations

Required Qualifications:

• Bachelor's degree in a relevant science discipline or equivalent work experience
• Minimum 5+ years of experience in clinical research, data management, or a related field
• Proficiency in at least one programming language (SAS, SQL, or R) with demonstrated expertise in data manipulation and analysis
• Hands-on experience working with at least two clinical data management systems (such as SAS, Workbench, or Elluminate)
• Strong knowledge of ICH-GCP, regulatory requirements, SOPs, system life cycle methodologies, and applicable regulations including 21 CFR Part 11
• Demonstrated leadership experience mentoring team members and managing technical projects
• Excellent written and oral communication skills in English with the ability to present complex technical information clearly to diverse audiences