Principal Clinical Programmer

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

Job Description: Job Title: Principal Clinical Programmer Location: India (Remote) About the Role We are seeking an experienced Principal Clinical Data Programmer to join our Clinical EDC Programming team at Caidya. This role combines advanced technical expertise with clinical data strategy, collaborative problem-solving, and leadership in the evolution of clinical database design and integrated data management. As the clinical research industry increasingly embraces quality by design, risk-based approaches, analytics, and AI-enabled technologies, the role of Clinical Programming is expanding beyond traditional database development. Our Principal Clinical Programmers are expected to help shape how studies are designed and configured, applying their technical knowledge alongside an understanding of protocol objectives, critical-to-quality factors, and downstream data review needs. The ideal candidate will bring extensive hands-on experience with Medidata Rave EDC, including advanced Custom Function programming, complex study builds, and clinical system integrations. Experience with Veeva Vault CDMS is preferred, while exposure to Medidata Designer, Clinical Data Studio (CDS), analytics, and AI-assisted workflows is an advantage. Working closely with Data Management, Clinical Operations, sponsors, and other cross-functional teams, this individual will provide technical leadership, challenge traditional approaches where appropriate, influence database design decisions, and help advance Caidya's transition toward more integrated, efficient, and data-driven clinical trial processes. Key Responsibilities Provide technical leadership in the design, configuration, validation, and maintenance of complex clinical study databases in accordance with study protocols, SOPs, GCP, and regulatory requirements. Partner with Data Management and other study functions to translate protocol objectives, critical-to-quality factors, and data review requirements into effective clinical database design strategies. Lead collaborative database design discussions, evaluating alternative approaches and recommending solutions that balance data quality, operational efficiency, study complexity, and downstream analytics needs. Develop and maintain advanced edit checks, derivations, custom programming, and complex database configurations, providing expert guidance across EDC platforms. Provide technical oversight for complex study builds, database migrations, post-production changes, and integrations across clinical systems. Support the adoption and optimization of Medidata Designer, including AI-assisted study configuration and evolving approaches to protocol-driven database development. Contribute to the implementation and optimization of Clinical Data Studio (CDS), supporting integrated data review, analytics, external data ingestion, and risk-based data management capabilities. Collaborate with Data Management, Clinical Operations, Biostatistics, Medical Monitoring, sponsors, and external partners to develop solutions that support cross-functional data review and high-quality clinical data delivery. Apply quality-by-design and risk-based principles to database configuration, validation strategies, and clinical data workflows. Provide technical expertise in evaluating complex programming challenges, system limitations, integration requirements, and opportunities for process improvement. Contribute to programming standards, global libraries, technical guidelines, and governance processes that support consistency and efficient study delivery. Mentor Clinical Programmers, promote critical thinking and collaborative problem-solving, and support the team's transition toward more consultative and strategically engaged roles. Identify and champion opportunities to improve clinical programming through automation, analytics, AI-assisted workflows, and emerging technologies. Collaborate with programming leadership and study teams to assess technical requirements, man

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