Senior Clinical Programmer

CaidyaIndia - (home based)remoteSalary not postedView the original posting at Caidya ↗

Job Description: Job Title: 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;

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