EDC Developer / EDC Builder

This is a contract-based position in India . We are looking for someone with strong hands-on experience in EDC database build/configuration , particularly around eCRFs, edit checks, validation rules, EDC testing/UAT, and clinical data standards .

The key requirement is someone who has practical experience working on EDC platforms such as Medidata Rave, Oracle InForm, Veeva EDC, or similar , along with good knowledge of CDISC, SDTM, and ADaM specifications .

I’ve included the detailed JD below for your reference:

Position: EDC Developer / EDC Builder

Location: India - Remote

Employment Type: Contract

Position Overview

We are looking for an experienced EDC Developer/Builder to support the design, development, testing, and maintenance of EDC systems for clinical trials. The ideal candidate will have strong hands-on experience with EDC database builds, eCRFs, edit checks, data validation, SDTM/ADaM specifications, and clinical data standards .

Key Responsibilities

• Build and configure EDC clinical study databases based on protocols, CRF specifications, and study requirements.
• Design and develop eCRFs, forms, visits, folders, and study workflows .
• Develop and implement edit checks, validation rules, derivations, and data validations .
• Develop and review SDTM and ADaM specifications and ensure alignment with clinical data requirements.
• Translate clinical and statistical specifications into EDC/database configurations.
• Configure roles, permissions, workflows, and user access .
• Perform unit testing, UAT, validation, and issue resolution .
• Support database build, testing, deployment, amendments, and database lock activities.
• Work closely with Clinical Data Management, Biostatistics, Statistical Programming, Clinical Operations, and other cross-functional teams .
• Troubleshoot EDC configuration and data issues.
• Maintain technical documentation and ensure compliance with SOPs, GCP, and applicable regulatory requirements .

Must-Have Skills

• 2+ years of hands-on EDC development/build experience .
• Experience with Medidata Rave, Oracle InForm, Veeva EDC, or similar EDC platforms .
• Strong experience with eCRF/database development and configuration .
• Hands-on experience developing edit checks and validation rules .
• Experience with SDTM and ADaM specifications .
• Understanding of CDISC standards , including SDTM and ADaM.
• Experience with EDC testing, UAT, validation, and troubleshooting .
• Strong understanding of clinical trials and clinical data management processes .
• Knowledge of GCP and regulatory requirements .
• Strong analytical, documentation, and problem-solving skills.

Education

Bachelor's degree or higher in Life Sciences, Clinical Research, Computer Science, Statistics, Biostatistics, or a related field preferred.