Job Summary
We are seeking an experienced Medidata Rave Programmer with 5+ years of hands-on experience in Medidata Rave Architect, including CRF design, Edit Check development, and Custom Function (CF) programming. The candidate will be responsible for building, validating, and maintaining Rave studies while ensuring compliance with clinical data standards and quality requirements.
Key Responsibilities
- Design and develop CRFs in Medidata Rave Architect.
- Develop, test, and maintain complex Custom Functions (CFs) and Edit Checks.
- Review CRF and Edit Check specifications for completeness and accuracy.
- Perform unit testing, UAT support, and validation activities.
- Conduct peer reviews of CRFs, Edit Checks, and Custom Functions.
- Migrate study builds, edit checks, and custom functions across environments.
- Support Rave library management and standards implementation.
- Assess impact of Rave upgrades and perform regression testing.
- Collaborate with Clinical Data Management, Programming, and Study Teams.
- Maintain development documentation and ensure compliance with SOPs and regulatory requirements.
Required Skills
- 5+ years of experience in Medidata Rave Architect.
- Robust expertise in:
- CRF Design & Build
- Edit Check Development
- Custom Function (CF) Development
- Rave Migration Activities
- Study Build and Validation
- Experience with Medidata Rave eCRF lifecycle management.
- Understanding of clinical trial data collection processes.
- Knowledge of GCP, ICH, and regulatory compliance requirements.
- Strong analytical, troubleshooting, and communication skills.
Preferred Skills
- Experience with Rave Library Management.
- Exposure to Lab Administration module in Rave.
- Knowledge of CDISC standards (SDTM).
- Experience supporting global clinical studies.
- Understanding of metadata-driven clinical data standards. Educational Qualification
Bachelor's or master’s degree in computer science, Life Sciences, Statistics, Information Systems, or related