Senior Clinical Programmer

Location: India (Remote)

About the Role

We are seeking an experienced Senior Clinical Programmer to join our Clinical EDC Programming team at Caidya. This role combines strong technical programming expertise with an understanding of clinical trial design, data quality, and the evolving role of technology in clinical data management.

As clinical data management moves toward more integrated, risk-based, and analytics-driven approaches, our Clinical Programmers play an increasingly important role in shaping how study data is collected, validated, and reviewed. Working collaboratively with Data Management and other study functions, the Senior Clinical Programmer will contribute to database design decisions, evaluate study requirements, and develop solutions that support efficient study execution and high-quality clinical data.

The ideal candidate will have strong hands-on experience with Medidata Rave EDC, including edit checks, derivations, and Custom Functions, along with an interest in emerging technologies and new ways of working. Experience with Veeva Vault CDMS is preferred, while exposure to Medidata Designer, Clinical Data Studio (CDS), analytics, and AI-assisted workflows is an advantage.

This is an opportunity to contribute beyond traditional database programming, helping Caidya advance its clinical data capabilities through collaboration, innovation, and continuous improvement.

Key Responsibilities

• Design, configure, validate, and maintain clinical study databases in accordance with study protocols, SOPs, GCP, and regulatory requirements.
• Collaborate with Data Management and other study functions to interpret protocol requirements, identify critical data collection needs, and develop appropriate database design solutions.
• Participate actively in database design discussions, providing recommendations that consider data quality, usability, downstream review requirements, and study objectives.
• Develop and maintain eCRFs, edit checks, derivations, Custom Functions, and other clinical database components within EDC.
• Support study build, amendments, migrations, and post-production changes, evaluating the impact of proposed changes on data collection and review processes.
• Contribute to database configuration and review activities, including the adoption of AI-assisted study build capabilities and evolving technologies.
• Support Clinical Data Studio (CDS) configuration, data ingestion, listings, and analytics-related activities as applicable.
• Apply an understanding of risk-based data management and critical-to-quality factors when developing and validating clinical database solutions.
• Collaborate with Data Management, Clinical Operations, Biostatistics, Medical Monitoring, sponsors, and external vendors to resolve technical and data-related challenges.
• Participate in UAT, production deployment, troubleshooting, and resolution of programming and database issues.
• Communicate programming progress, risks, dependencies, and recommendations to study teams and programming leadership.
• Contribute to programming standards, global libraries, process improvements, and the adoption of new technologies and ways of working.
• Support and mentor less experienced Clinical Programmers, promoting knowledge sharing, collaboration, and continuous learning.

Qualifications

• Bachelor's degree or advanced degree in computer science, life sciences, health informatics, mathematics, or a related field, or equivalent combination of education and experience.
• Minimum 5 years of experience in clinical database programming, EDC study design, and development within the pharmaceutical, biotechnology, or CRO industry.
• Strong hands-on experience with Medidata Rave EDC required, including study build, edit checks, derivations, and database configuration.
• Experience with Custom Function programming, C#, database migrations, and post-production change activities preferred.
• Experience with Veeva Vault CDMS preferred; Medrio and Oracle InForm experience are also beneficial.
• Experience with Medidata Designer and/or Clinical Data Studio (CDS) is a plus.
• Understanding of clinical trial processes, protocol requirements, GCP, regulatory expectations, and clinical data standards.
• Familiarity with risk-based data management, critical-to-quality principles, centralized data review, or clinical data analytics is beneficial.
• Interest in emerging technologies, automation, AI-assisted workflows, and their application to clinical data management.
• Strong analytical and problem-solving skills, with the ability to evaluate requirements and recommend appropriate solutions.
• Effective communication and collaboration skills, including the ability to work with cross-functional teams and contribute to technical and operational discussions.
• Adaptability, curiosity, and a willingness to challenge traditional approaches and embrace evolving processes.
• Ability to work independently and manage competing priorities within a global, remote team.

Why Join Us?

• Be part of a growing, innovation-focused CRO where your expertise and ideas can directly contribute to how clinical data solutions are delivered.
• Help shape the future of clinical data management through integrated data review, analytics, and evolving AI-enabled technologies.
• Work with modern clinical platforms, including Medidata Rave, Designer, and Clinical Data Studio.
• Join collaborative global teams that value knowledge sharing, technical excellence, fresh perspectives, and continuous improvement.
• Enjoy the flexibility of a remote work environment that supports work-life balance.
• Gain exposure to diverse global studies, clients, and emerging clinical data strategies.
• Grow your technical and clinical data expertise while contributing to process improvement and innovation initiatives.
• Experience the agility and visibility of a mid-sized CRO where individual contributions make a meaningful impact.

If you are an experienced Clinical Programmer who enjoys solving problems, collaborating across disciplines, and exploring new approaches to clinical data management, we encourage you to apply.

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The company will not accept unsolicited resumes from third party vendors.