Clinical Systems Designer (PST/EST/CST Timezone)
Indeed
Salary undisclosed
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Description
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 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
- 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 CRIO and other CTMS builds.
Qualifications
Bachelor’s degree in Life Sciences, Clinical Research, or related field (or equivalent experience). At least 1 year of direct experience building e-source and e-regulatory in CRIO (required). Experience performing e-source and e-regulatory builds in Clinical Conductor and/or RealTime CTMS (strongly preferred).
Strong understanding of clinical trial protocols, regulatory compliance, and site operations. Ability to map procedures to budgets/financials in CTMS platforms. Strong attention to detail, documentation, and version control.
Excellent communication and collaboration skills. Preferred Skills Experience across multiple CTMS/EDC platforms (with e-source build
Responsibilities
). Process optimization and SOP development experience. Knowledge of site-level finance, billing, and reconciliation workflows.
Key Success Metrics Accuracy and compliance of e-source and e-regulatory builds. Timely completion of study build-outs . Reduction in errors, deviations, or billing mismatches.
Positive feedback from coordinators, investigators, and regulatory staff.
About this role
Indeed is hiring a Clinical Systems Designer to build and maintain the technical infrastructure that clinical trial sites depend on. You'd translate study protocols into compliant electronic source documents and regulatory binders in CRIO, with a strong preference for candidates who can also work in Clinical Conductor and RealTime CTMS. The role requires hands-on expertise in study configuration—visit schedules, assessments, workflows—alongside the ability to map procedures to financial tracking so billing aligns with actual study requirements.
Beyond system setup, you'd own quality control, gather feedback from coordinators and investigators, and refine builds accordingly. You'd also develop standard operating procedures, provide training and troubleshooting support to clinical teams, and collaborate across Clinical, Regulatory, and Finance departments to ensure builds meet both compliance standards (FDA, ICH-GCP, 21 CFR Part 11) and operational reality. This is a detail-intensive role where accuracy directly impacts study integrity and site efficiency.
The position requires at least one year of direct CRIO e-source and e-regulatory build experience and a bachelor's degree in Life Sciences or Clinical Research (or equivalent). Experience with Clinical Conductor or RealTime is strongly preferred. You'll need strong protocol literacy, regulatory knowledge, site operations familiarity, and solid documentation discipline. The role is full-time, in-office in Bogota, and works within PST/EST/CST timezones.
How this employer is doing
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Pay for this role
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