421314 EDC Programmer

# Job Description: EDC Programmer – Veeva CDMS

**Job Code:** 421314\

**Job Title:** EDC Programmer\

**Domain:** Clinical Data Management / Life Sciences\

**Band:** BPO 4\

**Location:** Mumbai, Maharashtra\

**Salary:** Up to ₹12 LPA\

**Shift:** General Shift\

**Work Mode:** As per employer requirements

## Job Summary

We are looking for a skilled EDC Programmer with experience in Electronic Data Capture (EDC) systems and clinical data management. The candidate will be responsible for designing and developing electronic Case Report Form (eCRF) screens, configuring study-specific settings, programming edit checks, and performing testing and validation activities using Veeva Studio and Veeva CDMS.

The ideal candidate must have international BPO experience, a completed graduation degree, and the ability to work collaboratively with Clinical Data Management teams to deliver high-quality clinical study databases.

## Key Responsibilities

### 1\. eCRF Development and Configuration

- Read and interpret clinical study protocols to identify data points and incorporate them into eCRF specifications.

- Develop eCRF screens according to approved specifications using Veeva Studio.

- Configure Source Data Verification (SDV), Source Data Review (SDR), safety, and coding functionalities within Veeva CDMS.

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

- Document decisions, issues, and action items during design meetings.

- Communicate development timelines, project status, and potential delays to relevant stakeholders.

### 2\. Edit Checks and Programming

- Review edit check specification documents for clarity, accuracy, and consistency with eCRF designs.

- Develop study-specific edit checks, Protocol Deviation checks, and email checks.

- Apply Veeva Rules best practices when creating and maintaining programming rules.

- Validate programmed functionality and perform developer-level testing.

- Provide User Acceptance Testing (UAT) details to the Validation Team and Study Data Manager.

- Incorporate feedback received from test script execution and resolve identified issues.

### 3\. Documentation and Go-Live Activities

- Complete all activities specified in the developer checklist.

- Coordinate Go-Live and training communication with the Study Data Lead (SDL).

- Review and promote study documentation, including SDS, annotated eCRFs, T&E, and blank eCRFs, within the electronic Trial Master File (eTMF) system.

- Ensure that required documents are maintained in Veeva eTMF and the Project Binder.

### 4\. Post-Go-Live Changes

- Review change control requests and understand the required modifications.

- Perform impact analysis and recommend appropriate approaches for implementing changes.

- Modify eCRF screens and update study-specific rules in Veeva CDMS.

- Conduct unit testing for screen changes and edit checks.

- Review changes in the test environment for existing, new, frozen, and locked subjects.

- Complete all activities outlined in the Post-Go-Live checklist.

### 5\. General Responsibilities

- Support database design, programming, validation, and clinical data transfers.

- Perform quality control procedures to maintain accuracy and data integrity.

- Provide technical expertise to the Clinical Data Management team.

- Create, review, and update Data Management Plan documents.

- Maintain effective communication with Data Managers, Study Data Managers, customers, and project stakeholders.

- Follow SOPs, regulatory requirements, and project-specific guidelines.

- Escalate unresolved issues to the appropriate stakeholders.

- Prepare and provide regular project status reports.

- Identify opportunities for process improvement and participate in knowledge sharing.

## Required Qualifications

- Bachelor's degree in a relevant scientific or technical discipline preferred.

- Graduation is mandatory.

- International BPO experience is mandatory.

- Practical experience with EDC programming and clinical data management is highly relevant.

- Experience with Veeva Studio and Veeva CDMS is essential for the described responsibilities.

## Required Skills

- Knowledge of eCRF design, development, and configuration.

- Understanding of clinical study protocols and eCRF specifications.

- Experience in programming and validating edit checks.

- Familiarity with SDV, SDR, safety configuration, and medical coding workflows.

- Knowledge of UAT, unit testing, change control, and database validation.

- Understanding of clinical data management documentation and regulatory compliance.

- Strong analytical, troubleshooting, and problem-solving skills.

- Good written and verbal communication skills.

- Ability to manage multiple tasks, meet deadlines, and work collaboratively with cross-functional teams.

## Mandatory Eligibility Criteria

- **Current location:** Mumbai candidates only. CVs of candidates who are not currently based in Mumbai must be rejected.

- **Education:** Graduation is compulsory.

- **Experience:** International BPO experience is mandatory.

- **Rehire policy:** Former TCS employees are not eligible.

- **Compensation:** Up to ₹12 LPA.

- **Shift:** General shift.

## Candidate Profile

The ideal candidate will have a strong understanding of clinical data management and EDC programming, hands-on knowledge of Veeva Studio and Veeva CDMS, and the ability to manage eCRF development, edit checks, testing, documentation, and post-Go-Live changes while adhering to project timelines and quality standards.

**Employee profile requirement:** PAN and Date of Birth (DOB) details are required for profile creation, subject to applicable data privacy and verification policies.