EDC Developer / EDC Builder

ACL Digital; India; A distancia; INR 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

ACL Digital is seeking an experienced EDC Developer/Builder to design, build, test, and maintain EDC systems for clinical trials. The role requires hands-on work on EDC databases, eCRFs, edit checks, and data validation in line with SDTM/ADaM standards.

The candidate will implement SDTM/ADaM specifications, ensure regulatory compliance (GCP), and collaborate with CDM, Biostatistics, and Operational teams. Remote India-based contract position with strong data management focus.

Formación

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

Responsabilidades

• Build and configure EDC clinical study databases based on protocols and CRF specs.
• Design and develop eCRFs, forms, visits, folders, and study workflows.
• Develop and implement edit checks, validation rules, derivations, and data validations.
• Review SDTM and ADaM specifications and align with clinical data requirements.
• Translate clinical and statistical specifications into EDC 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.
• Collaborate with Clinical Data Management, Biostatistics, Statistical Programming, Clinical Operations, and cross-functional teams.
• Troubleshoot EDC configuration and data issues.
• Maintain technical documentation and ensure SOPs and regulatory compliance.

Conocimientos

EDC development

Medidata Rave

Oracle InForm

Veeva EDC

eCRF development

SDTM/ADaM basics

GCP knowledge

Data validation

Documentation

Troubleshooting

Educación

Bachelor's degree or higher in Life Sciences/Clinical Research/CS/Statistics

Descripción del empleo

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:

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.