Senior Electronic Data Capture Specialist

1 day ago


Delhi, Delhi, India Tata Consultancy Services Full time
Job Overview
Tata Consultancy Services is seeking an experienced EDC Programmer to join their team in Mumbai, Pune, Bangalore, Indore, or Ahmedabad. As an EDC Engineer, you will work on EDC activities and oversee the delivery of systems and documentation to support clinical studies.

About the Role
We are looking for a skilled EDC Programmer to develop eCRF specifications, build or oversee implementation of Case Report Forms (eCRFs) for clinical trials. You will manage and oversee EDC system configuration and dictionaries, create and own database build SOPs and processes, and provide consulting services to ensure the implementation of technology.

Main Responsibilities
  • Create eCRF specifications, design, develop, and unit test clinical trial setup process.
  • Create edit check specifications and program or modify checks at study level within EDC.
  • Setup different instances of study URL (e.g., UAT, production, testing, etc.).
  • Setup and configure user accounts for study teams.
  • Setup and manage blinded and unblinded study configurations.
  • Be the SME for all database-related activities.
  • Setup, configure, unit test, and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs, etc.
  • Familiar with custom functions within EDC systems.
  • Work closely with EDC vendors regarding any tool-related issues in the system.
  • Ability to troubleshoot database setup as per study needs.
  • Prepare, test, and implement post-production changes as per study needs.
  • Archive and retire the study URL after database lock.
  • Partner with appropriate team members to establish technology standards and governance models.

Requirements
  • Veeva is mandatory.

Estimated Salary Range: ₹12,00,000 - ₹25,00,000 per annum, depending on experience.

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