Senior Clinical Database Programmer

Parexel International; India; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Parexel International is seeking a Senior Clinical Database Programmer on a 6-month contractual assignment to support clinical database programming and ensure high-quality data delivery for clinical studies. You will design, implement, and maintain EDC/CDMS systems while ensuring regulatory compliance and data integrity across trials.

You will provide technical leadership, mentor programming teams, and collaborate with sponsors and data management leaders to drive quality and efficiency in trial

Qualifications

• 6 to 7 years of experience in clinical data programming.
• Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).
• Strong knowledge of SOPs, guidelines, work instructions, SDLC methodologies, ICH-GCP, and regulatory requirements including 21 CFR Part 11.
• Demonstrated experience in the clinical research industry or similar regulated environment.
• Strong communication, organization, and problem-solving skills with proven ability to work independently and collaboratively.

Responsibilities

• Lead and supervise the design, implementation, and maintenance of electronic data capture (EDC) and clinical database management systems (CDMS) in standard or CDISC-compliant formats, ensuring regulatory compliance and first-time quality on all deliverables.
• Create, implement, and maintain consistency checks and edit checks in standard or CDISC format, following internal SOPs and external regulatory requirements including 21 CFR Part 11 and ICH-GCP guidelines.
• Provide technical leadership and mentorship to programming teams and project staff, including training on eCRF design, database procedures, and best practices in clinical data management.
• Serve as the primary technical contact and liaison with sponsors, data management leaders, and cross-functional teams regarding database programming issues, technical solutions, and project timelines.
• Manage database lock/unlock procedures and approve database changes in accordance with SOPs, ensuring adherence to service level agreements and regulatory requirements.
• Maintain comprehensive technical and regulatory documentation for clinical databases, including deviation logs and traceability records to ensure compliance and audit readiness.
• Support the integration and programming of systems within the Global Data Operations area, including CTMS, safety systems, and coding systems, while executing multiple programming languages and processes.
• Develop, improve, and implement project-specific tools and standards that enhance efficiency and optimize clinical trial processes across multiple concurrent projects.
• Participate in business development activities, including bid defense meetings and technical support for new business opportunities.

Skills

Strong communication

Problem-solving

Leadership

Mentoring

Regulatory knowledge

Education

Bachelor's degree in relevant science discipline or equivalent work experience

Certification in clinical systems platform (e.g., Inform, RAVE, DataLabs, Medrio, Veeva)

Tools

SAS

CDMS

EDC

SQL

VB

Java

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

Join our team as a Senior Clinical Database Programmer on a 6-month contractual assignment. In this role, you will be responsible for supporting clinical database programming and ensuring high-quality data delivery for clinical studies.

As a Senior Clinical Database Programmer, you will provide technical expertise and strategic leadership in the design, implementation, and management of electronic data capture (EDC) systems and clinical databases that directly impact the integrity and success of clinical trials. This position plays a key role in ensuring regulatory compliance, data accuracy, and system optimization while advancing patient safety and research quality. You'll collaborate with cross-functional teams including sponsors, data management leaders, and clinical operations, follow industry-standard processes and regulatory requirements, and contribute to study operations from planning through closeout.

Responsibilities include leading EDC system setup and maintenance, designing and implementing consistency checks, mentoring programming teams, and supporting business development initiatives. With diverse teams and continuous learning opportunities, the Senior Clinical Database Programmer can explore career paths and expand skills across clinical research, positioning yourself as a trusted technical authority in clinical data management.

Key Responsibilities:

• Lead and supervise the design, implementation, and maintenance of electronic data capture (EDC) and clinical database management systems (CDMS) in standard or CDISC-compliant formats, ensuring regulatory compliance and first-time quality on all deliverables

• Create, implement, and maintain consistency checks and edit checks in standard or CDISC format, following internal SOPs and external regulatory requirements including 21 CFR Part 11 and ICH-GCP guidelines

• Provide technical leadership and mentorship to programming teams and project staff, including training on eCRF design, database procedures, and best practices in clinical data management

• Serve as the primary technical contact and liaison with sponsors, data management leaders, and cross-functional teams regarding database programming issues, technical solutions, and project timelines

• Manage database lock/unlock procedures and approve database changes in accordance with SOPs, ensuring adherence to service level agreements and regulatory requirements

• Maintain comprehensive technical and regulatory documentation for clinical databases, including deviation logs and traceability records to ensure compliance and audit readiness

• Support the integration and programming of systems within the Global Data Operations area, including CTMS, safety systems, and coding systems, while executing multiple programming languages and processes

• Develop, improve, and implement project-specific tools and standards that enhance efficiency and optimize clinical trial processes across multiple concurrent projects

• Participate in business development activities, including bid defense meetings and technical support for new business opportunities

You'll thrive in this role if you bring:

• Technical expertise in clinical database programming, EDC systems, and CDMS platforms with a proven track record of delivering high-quality, compliant solutions

• Strong leadership and mentoring capabilities with the ability to guide and motivate virtual teams across multiple time zones and cultures

• Excellent communication skills with the ability to translate complex technical concepts for diverse audiences including sponsors, regulatory bodies, and internal stakeholders

• Deep understanding of regulatory requirements, ICH-GCP, 21 CFR Part 11, and SDLC methodologies with demonstrated commitment to quality and compliance

• Problem-solving mindset with the ability to make sound decisions in ambiguous situations and conduct root cause analyses

• Flexibility and adaptability with a commitment to continuous learning in an evolving technical environment

Required Qualifications

• 6 to 7 years of experience in clinical data programming

• Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java)

• Strong knowledge of SOPs, guidelines, work instructions, SDLC methodologies, ICH-GCP, and applicable regulatory requirements including 21 CFR Part 11

• Demonstrated experience in the clinical research industry or similar regulated environment

• Strong communication, organization, and problem-solving skills with proven ability to work independently and collaboratively

Preferred Qualifications

• Bachelor's degree in relevant science discipline or equivalent work experience

• Certification in at least one clinical systems platform (e.g., Inform, RAVE, DataLabs, Medrio, Veeva)

• Experience with multiple systems used in clinical trial processes (e.g., CTMS, medical safety reporting systems, or additional EDC platforms)

• Presentation skills and experience supporting business development activities

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.