Clinical Systems Designer (PST/EST/CST Timezone)
IndeedJohannesburg, South Africa · Posted 1 month agoDescription
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 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 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.
Similar jobs
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 CRI…
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 CRI…
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 CRI…
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 CRI…
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 CRI…
Est. 85,000 USD
Join Us in Shaping the Future of Clinical Research Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromisi…
Est. 120,000 USD
About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, ta…
Est. 140,000 USD
About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, ta…
Est. 140,000 USD
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Est. 120,000 USD
Join Us in Shaping the Future of Clinical Research Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromisi…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Est. 120,000 USD
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases.…
Est. 120,000 USD
Join Us in Shaping the Future of Clinical Research Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromisi…
Est. 85,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 140,000 USD
Company: At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases o…
Est. 250,000 USD
About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatme…
Est. 85,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 85,000 USD
Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 250,000 USD
About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatme…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 115,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 165,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 160,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 250,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 85,000 USD
Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from…
Est. 105,000 USD
Project Controls Manager Positional Summary The Project Controls Manager is responsible for establishing, implementing, training, and auditing all project controls. The project controls activities include oversight of al…
Est. 65,000 USD
Join Us in Shaping the Future of Clinical Research Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromisi…
Est. 65,000 USD
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop diffe…