Clinical Database Programmer II

Parexel; India; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Parexel is seeking a Clinical Database Build Programmer II to join our clinical data management team in India. You will design and implement database structures, ensure data quality, and support trial activities from planning through closeout.

You will work with cross-functional teams, adhere to ICH-GCP and 21 CFR Part 11, and contribute to CDISC standards and SDLC processes. The role offers learning opportunities across EDC, CDMS, and programming environments in a regulated setting.

Qualifications

• Bachelor's degree in a relevant science discipline or equivalent.
• Minimum 3 years of clinical data management or database programming.
• Experience in SAS, CDMS, EDC, SQL, VB or Java.
• Knowledge of SOPs, guidelines, and system life cycle methodologies.
• Knowledge of ICH-GCP and 21 CFR Part 11 regulations.

Responsibilities

• Design and implement database structures for clinical data management systems.
• Maintain consistency checks and regulatory compliance across builds.
• Deliver first-time quality on database-related deliverables.

Skills

Attention to detail

Communication skills (English)

Learning agility

Collaboration across teams

Organization

Problem-solving

Education

Bachelor's degree in relevant science

Tools

SAS

CDMS

EDC

SQL

VB

Java

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.

About the Role

We are seeking a Clinical Database Build Programmer II to join our team. As a Clinical Database Build Programmer II, you will support clinical research activities that advance new treatments for patients. This position plays a key role in database design, implementation, and quality assurance across clinical data management systems. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through closeout.

Responsibilities include designing and implementing database structures, creating and maintaining consistency checks, ensuring regulatory compliance, and supporting technical solutions for internal and external stakeholders. With diverse teams and continuous learning opportunities, the Clinical Database Build Programmer II can explore career paths and expand skills across clinical data management systems, electronic data capture, and clinical trial management.

Key Responsibilities

• Create, implement, and execute procedures to build and maintain database set-up for paper-based and web-based (EDC) clinical data management systems in standard or CDISC-compliant format as required, including annotation of case report forms where applicable
• Create, implement, and maintain consistency checks in standard or CDISC format for database builds, following internal and external regulatory requirements
• Deliver first-time quality on all database-related deliverables and maintain accountability for accuracy and compliance
• Provide technical feedback to study programmers on the creation of electronic case report forms following standard operating procedures and internal process guidelines
• Assist in providing technical solutions to internal and external client inquiries related to database design and implementation
• Develop and expand knowledge of clinical data management systems, electronic data capture, clinical trial management systems, safety reporting, and programming languages used within the organization
• Maintain all supporting documentation for studies in accordance with standard operating procedures and guidelines to ensure traceability and regulatory compliance
• Maintain technical documentation applicable to clinical databases and document any deviations for dissemination to project teams
• Participate in the creation of standards through tools, libraries, or processes to ensure efficient and effective database management practices

Candidate Profile

You'll thrive in this role if you bring:

• Strong attention to detail and commitment to quality in a regulated environment
• Excellent written and oral communication skills in English
• Ability to learn new systems and function effectively in an evolving technical environment
• Ability to collaborate across teams, including international teams, as well as work independently
• Strong organizational skills, ability to manage competing priorities, and flexibility to adapt to change
• Customer focus, commitment to quality management, and strong problem-solving abilities

Required Qualifications

• Bachelor's degree in relevant science discipline or equivalent work experience
• At least 3 years of experience in clinical data management or database programming
• Experience in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java)
• Knowledge of standard operating procedures, guidelines, and system life cycle methodologies
• Knowledge of ICH-GCP and applicable local and international regulations such as 21 CFR Part 11
• Strong communication, organization, and problem-solving skills

Preferred Qualifications

• Experience with electronic data capture (EDC) systems
• Familiarity with CDISC standards and CDMS platforms
• Experience in a clinical research or healthcare environment

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.