Clinical Systems Designer (Lima)

Clinical Systems Designer (Lima)

10 ago
|
Indeed
|
Lima

10 ago

Indeed

Lima

Job Description: Clinical Systems 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 adecuado 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 troubleshooting for CRI

📌 Clinical Systems Designer (Lima)
🏢 Indeed
📍 Lima

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