Job Title: Rave Programmer / Clinical Data Programmer (Medidata Rave)

Experience: 3 to 12 Years

Qualification: Any Graduate / BE

Location: Bangalore, relocation considered.

We are seeking an experienced Rave Programmer with a strong background in Clinical Data Management (CDM) and Electronic Data Capture (EDC) systems. The ideal candidate will be responsible for designing, building, validating, and maintaining clinical study databases using Medidata Rave while ensuring compliance with clinical trial standards and regulatory requirements.

This role requires close collaboration with Clinical Data Managers, Study Teams, and Sponsors to support clinical trials through efficient database development, edit check programming, and change management activities.

Key Responsibilities

- Design, develop, and maintain clinical study databases using Medidata Rave EDC.
- Build and configure Electronic Case Report Forms (eCRFs) based on study protocols and specifications.
- Develop and validate edit checks, derivations, custom functions, and data validation rules.
- Support protocol amendments and implement database updates through the change control process.
- Perform User Acceptance Testing (UAT), database validation, and quality checks.
- Collaborate with Clinical Data Management, Biostatistics, Programming, and Sponsor teams throughout the study lifecycle.
- Ensure compliance with CDISC standards, GCP, SOPs, and regulatory requirements.
- Participate in database lock activities and issue resolution.
- Prepare technical documentation, validation documents, and release notes.
- Troubleshoot database-related issues and recommend process improvements.

Required Skills

Mandatory

- 3 to 10 years of experience in Clinical Data Management or Clinical Data Programming.
- Strong hands-on experience with Medidata Rave EDC database build.
- Experience in:




- eCRF Design
- Edit Check Programming
- Custom Functions
- Database Validation
- UAT
- Database Deployment
- Protocol Amendments

- Good understanding of:

- Clinical Trial Lifecycle
- ICH-GCP Guidelines
- CDISC Standards
- Clinical Data Management Processes

- Experience working with cross-functional global clinical teams.
- Excellent analytical and problem-solving skills.

Preferred Skills

Candidates with experience in one or more of the following will be preferred:

- Elluminate Clinical Data Cloud
- Data ingestion and transformation pipelines
- Clinical data integration
- Automation workflows
- Spotfire
- Qlik
- JReview
- Cognos
- Business Objects (BOXI)
- SQL
- Clinical Reporting Tools

Soft Skills

- Solid communication and stakeholder management skills.
- Ability to work independently and within global teams.
- Adaptable and versatile in a fast-paced environment.
- Strong analytical and problem-solving abilities.
- Ability to work under pressure and meet project timelines.
- Quick learner with excellent attention to detail.

Preferred Domain Experience

- Clinical Data Management
- Clinical Trials
- CRO
- Pharmaceutical
- Biotechnology
- Life Sciences

Valuable to Have

- Experience working in sponsor/CRO environments.
- Exposure to multiple clinical studies across different therapeutic areas.
- Experience supporting database lock and study closeout activities.

Notice Period

Preferred candidates who can join immediately or within 30 to 60 days.

Suggested Naukri/LinkedIn Keywords

- Medidata Rave
- Rave Programmer
- Clinical Data Programmer
- Clinical Data Management
- EDC Build
- eCRF Design
- Edit Check Programming
- Clinical Trials
- CDISC
- ICH-GCP
- Database Build
- Clinical Data Services
- Elluminate
- Spotfire
- JReview
- Qlik
- CRO
- Pharma
- Life Sciences

📌 Rave Programmer / Clinical Data Programmer (Medidata Rave) (Karnataka)
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📍 Karnataka