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/new 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.