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 valuable 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.

📌 EDC Developer / EDC Builder (India)
🏢 ACL Digital
📍 India