EDC Programmer

EDC Programmer – Veeva CDMS

Location: Mumbai
Experience: Relevant EDC / Clinical Data Management experience
Shift: General Shift
Work Mode: Work from Office

Job Summary

TCS is hiring an EDC Programmer with hands-on experience in Veeva CDMS / Veeva Studio for Clinical Data Management activities. The role involves eCRF development, edit check programming, database configuration, validation, testing, post-go-live changes, and coordination with Data Management and study teams.

Key Responsibilities

• Read and understand study protocols and translate data requirements into eCRF specifications.

• Develop eCRF screens in Veeva Studio as per approved specifications.

• Configure SDV/SDR, Safety, and Coding within Veeva CDMS.

• Review edit check specifications and ensure checks are appropriate and consistent with eCRF design.

• Program study-specific rules, Protocol Deviation checks, and Email checks in Veeva.

• Conduct developer-level testing and unit testing of eCRFs and edit checks.

• Participate in and lead eCRF design meetings with Data Managers and study teams.

• Document decisions, issues, and actions from design meetings.

• Provide UAT details to the Validation Team and Study Data Manager.

• Review and manage relevant documents in the Veeva eTMF / Project Binder.

• Support Go-Live and training activities.

• Perform impact analysis and implement post-Go-Live change requests.

• Update eCRF screens, edit checks, and study-specific rules based on approved changes.

• Review changes in the testing environment for different subject statuses.

• Support database design, programming, validation, and data management activities.

• Perform quality control and ensure compliance with SOPs and regulatory requirements.

• Provide technical expertise to the Clinical Data Management team.

• Maintain effective communication with Data Management and project stakeholders.

• Prepare status updates and escalate unresolved issues appropriately.

• Contribute to process improvements, knowledge sharing, and lessons learned.

Required Skills

• Veeva CDMS

• Veeva Studio

• EDC Programming

• eCRF Development

• Edit Check Programming

• Clinical Data Management

• Database Design & Validation

• SDV / SDR Configuration

• Veeva Rules

• UAT / Developer Testing

Required Qualifications

• Graduation is compulsory.

• Bachelor's degree in a Scientific / Technical discipline is preferred.

• Hands-on experience with Veeva CDMS / Veeva Studio is required.

• International BPO experience is mandatory.

• Strong understanding of Clinical Data Management and EDC programming processes.

• Good communication and stakeholder management skills.

Important Eligibility / Rejection Criteria

• Candidate must currently be based in Mumbai.

• Reject CVs of candidates who are not in Mumbai.

• International BPO experience is mandatory.

• Reject CVs without International BPO experience.

• Former TCS employees are not eligible.

• TCS rehires are not accepted.

• Graduation is compulsory.

• PAN and DOB are required for Employee Profile creation