Job Title : EDC Programmer

Job Description:
The EDC Programmer will be responsible for developing and configuring electronic Case Report Forms (eCRFs) and study-specific programming requirements within Veeva CDMS. The role involves understanding clinical study protocols, translating data points into eCRF specifications, developing eCRF screens in Veeva Studio, configuring SDV/SDR, Safety and Coding, programming edit checks and protocol deviation checks, and performing developer-level validation and testing. The EDC Programmer will also support post-Go-Live changes, impact analysis, eCRF modifications, edit-check updates, testing, documentation, and data management activities while ensuring adherence to SOPs, regulatory requirements, and project-specific guidelines.

Key Responsibilities:

- Read and understand study protocols and incorporate required data points into specifications.

- Participate in study discussions with Data Managers and contribute to eCRF design activities.

- Lead and conduct eCRF Design Meetings and document decisions/issues.

- Develop eCRF screens as per specifications using Veeva Studio .

- Configure SDV/SDR, Safety, and Coding within the Veeva CDMS tool.

- Review edit-check specifications for clarity, consistency, and appropriateness.

- Program study-specific checks, Protocol Deviation checks, and Email Checks using Veeva Rules.

- Perform validation and developer-level testing.

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

- Complete activities specified in developer checklists.





- Review and promote SDS, Annotated eCRF, TandE, Blank eCRF, and other relevant files in the eTMF system.

- Confirm required documentation in the eTMF system and Project Binder.

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

- Perform eCRF screen changes, unit testing, and edit-check updates in Veeva CDMS.

- Review changes in the PPT environment for existing/recent and frozen/locked subjects.

- Perform database design, programming, validation, and data-management activities.

- Perform quality-control procedures and provide technical expertise to the Clinical Data Management team.

- Maintain effective communication with DM teams and stakeholders.

- Adhere to SOPs, regulatory requirements, and project-specific guidelines.

- Escalate unresolved issues and provide regular project status updates.

- Proactively identify process improvements and support knowledge transfer.

Qualifications:

- Graduation is compulsory.

- Bachelor's degree in a Scientific or Technical discipline is preferable.

- International BPO experience is mandatory.

Important Eligibility:

- Candidates must currently be based in Mumbai. CVs of candidates not in Mumbai should be rejected.

- International BPO experience is mandatory.

- Graduation is compulsory.

- Former TCS employees / TCS rehires are not eligible.

- PAN and DOB are required for profile creation.

- Hands-on experience with Veeva Studio / Veeva CDMS and eCRF development is required for the role.

📌 EDC Programmer (Mumbai)
🏢 Gratitude
📍 Mumbai