Job Description: Clinical Trials E-Source Designer

Position Summary

We are seeking a detail-oriented E-Source Builder with hands-on experience designing and maintaining electronic source documents and e-regulatory binders in CRIO (required). The ideal candidate will also have experience performing the same role in Clinical Conductor and/or RealTime CTMS, including study build-out, procedure mapping, financial integration, and regulatory binder setup. This role is essential to ensuring studies are configured accurately and efficiently across systems, supporting both compliance and operational excellence.

Key Responsibilities
- Study Build-Out
- Translate study protocols into compliant, user-friendly e-source templates in CRIO.
- Build study visit schedules, assessments, procedures, and workflows in CRIO, and ideally in Clinical Conductor and RealTime as well.
- Ensure builds meet sponsor/CRO requirements and site operational needs.
- E-Regulatory Setup & Compliance
- Develop and maintain electronic regulatory binders in CRIO,



with preference for experience doing the same in Clinical Conductor and RealTime.
- Ensure compliance with FDA, ICH-GCP, and 21 CFR Part 11 regulations.
- Standardize filing procedures and QC document uploads.
- Financials & Budget Integration
- Map study procedures to financial tracking in CRIO, with the ability to replicate this process in Clinical Conductor and RealTime.
- Collaborate with finance teams to align billing with study requirements.
- Ensure contracted budgets are accurately linked to procedures and site invoicing.
- Quality & Process Improvement
- Develop SOPs and best practices for e-source and e-regulatory build processes.
- Perform QC checks, gather coordinator/investigator feedback, and update builds accordingly.
- Maintain full documentation and version control for study builds.
- Collaboration & Training
- Partner with Clinical, Regulatory, and Finance teams to deliver accurate builds.
- Provide training, support, and tr

📌 E-Source Designer (New Delhi)
🏢 Indeed
📍 New Delhi