EDC Programmer
Gratitude IncEDC Programmer
Job Description
Key Skills
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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
Role
Business Analyst
Timings
Day Shift (Permanent)
Industry
Medical / Healthcare / Hospital
Work Mode
Work from office
Process
Non-Voice
Functional Area
IT Software/Hardware
Note: Myglit doesn't charge any money from candidates. If you have been asked to pay money to get this job then report to us immediately at support@myglit.com.
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