EDC Programmer

Job Title : EDC Programmer – Veeva CDMS

Location: Mumbai / Pune / Bangalore / Hyderabad
Experience: Relevant EDC Programming / Clinical Data Management Experience
Work Mode: Work From Office
Shift: General Shift

Job Description

We are hiring an experienced EDC Programmer to support clinical data management activities, database design, eCRF development, programming, configuration, testing, validation, and post-go-live changes using Veeva CDMS and Veeva Studio.

The ideal candidate should have strong experience in eCRF development, edit check programming, SDV/SDR, safety and coding configuration, along with exposure to clinical trials and international BPO operations.

Key Responsibilities

• Read and understand clinical study protocols and incorporate data points into eCRF specifications.

• Develop eCRF screens in Veeva Studio according to approved specifications.

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

• Lead and participate in eCRF design meetings with Data Managers and study teams.

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

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

• Perform developer-level validation, unit testing, and troubleshooting.

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

• Maintain developer checklists and required project documentation.

• Review and promote SDS, Annotated eCRF, T&E, Blank eCRF, and related documents in the eTMF system.

• Perform impact analysis and implement post-go-live change requests.

• Modify eCRF screens and update/create study-specific rules as required.

• Perform unit testing for eCRF changes and edit checks.

• Support testing, validation, database design, programming, and data transfers.

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

• Provide technical expertise and support to the Clinical Data Management team.

• Participate in client/study meetings and provide regular project status updates.

• Identify and recommend process improvements.

• Support knowledge transfer and sharing of best practices.

Required Skills

• Strong hands-on experience with Veeva CDMS and Veeva Studio.

• Experience in EDC programming and eCRF development.

• Knowledge of SDV, SDR, Safety, and Coding configuration.

• Experience programming edit checks and Veeva Rules.

• Understanding of clinical trial protocols and Clinical Data Management.

• Experience with database design, validation, testing, and data transfers.

• Strong analytical and problem-solving skills.

• Good written and verbal communication.

• Strong documentation and stakeholder management skills.

• Knowledge of SOPs, regulatory requirements, and clinical data management processes.

• Ability to work effectively with Data Managers, Study Data Leads, Validation Teams, and clients.

Qualifications

• Bachelor's degree is mandatory.

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

• Relevant experience in EDC Programming / Clinical Data Management.

• International BPO experience is mandatory.

Important Notes

• Former TCS employees are not eligible for this position.

• International BPO experience is mandatory. Candidates without international BPO experience should not be considered.

• Candidates must currently be located in Mumbai, Pune, Bangalore, or Hyderabad.

• Graduation is compulsory.

• Ex TCS Employees can't apply

• PAN and DOB are required for profile creation