Principal Clinical Programmer
Location: India (Remote)
About the role
We are seeking an experienced Principal Clinical Data Programmer with deep expertise in Medidata Rave EDC, including Custom Function programming and advanced study build activities. This role will support the design, configuration, validation, and optimization of clinical databases across global clinical trials while contributing to innovation initiatives involving Clinical Data Studio, analytics, and modern data review technologies.
Key Responsibilities
- Design, configure, validate and maintain clinical study databases in compliance with study protocols, SOPs, GCP, and regulatory requirements
- Develop and maintain edit checks, custom functions, and validation procedures within Medidata Rave EDC
- Support advanced study build activities using Medidata Designer and contribute to centralized data review workflows within Clinical Data Studio (CDS)
- Collaborate with Data Management, Clinical Operations, Biostatistics, Medical Monitoring and external partners to support high-quality clinical data delivery
- Support analytics, risk-based quality management (RBQM), and modern data review initiatives through CDS and related clinical platforms
- Identify, troubleshoot, and resolve complex data quality, edit check and integration issues across clinical systems
- Contribute to standards development, process optimization, automation initiatives and continuous process improvement efforts
- Participate in protocol review, CRF design, Data Validation Specification (DVS) development, UAT and production deployment activities
- Mentor junior Clinical Programmers and provide technical guidance across projects and study teams
- Support innovation initiatives involving analytics, AI-enabled workflows, and emerging clinical data technologies