Software Developer (EDC) - Permanent - Bonita Springs, FL
Build the systems that power cleaner, smarter, compliant clinical data-end to end.
Proclinical is seeking a Software Developer specializing in Electronic Data Capture (EDC) and Development Data Cloud to join a team in Bonita Springs, FL.
Primary Responsibilities:
The successful candidate will collaborate with clinical study teams, data management, and statisticians to design, develop, and optimize data collection systems and processes. This position focuses on ensuring data integrity, compliance, and operational efficiency within clinical trials.
Skills & Requirements:
- Strong expertise in designing and developing EDC systems and cloud-based data solutions.
- Proficiency in configuring dictionaries (e.g., MedDRA, WHO Drug) and managing data validation rules.
- Experience with system integrations, workflow automation, and backend development using .NET framework.
- Familiarity with regulatory compliance standards (21 CFR Part 11, GDPR, ICH-GCP).
- Knowledge of SharePoint development and Azure DevOps environment.
- Ability to write clean, testable code and conduct thorough testing processes.
- Excellent problem-solving skills and ability to provide technical guidance.
- Bachelor's degree in Computer Science, Information Systems, Life Sciences, or related field (master's preferred).
The Software Developer's responsibilities will be:
- Collaborate with clinical study teams to review protocols and design CRF specifications and new data collection forms.
- Develop, test, and deploy Study Startup and EDC functionality, including forms, edit checks, custom functions, dynamic logic, visit schedules, and role-based access.
- Implement complex data validation rules, query logic, and automated checks to ensure data quality and consistency.
- Configure and manage dictionaries such as MedDRA, WHO Drug, lab normal ranges, unit conversions, and coding setups.
- Develop and maintain integrations between enterprise tracking systems, Dataverse, and clinical trial-related modules (e.g., eTMF, dashboards, safety reporting).
- Perform system enhancements and post-production changes while maintaining audit trails and version control.
- Conduct User Acceptance Testing (UAT), write test scripts, execute testing, and resolve defects.
- Ensure all deliverables comply with regulatory standards (21 CFR Part 11, GDPR, ICH-GCP) and internal SOPs.
- Develop reusable tables, libraries, standards, and templates to improve efficiency across programs.
- Provide technical guidance and troubleshooting support to study teams and site users.
- Participate in process improvement initiatives and adopt new technologies.
- Automate workflows using Power Automate to streamline business and GxP processes.
- Develop scalable backend services using .NET framework for seamless integration with Microsoft Dataverse.
- Support SharePoint development, including custom workflows, forms, and site management.
- Write clean, testable code and implement unit tests for continuous integration in Azure DevOps.
- Conduct regression testing and validate applications for reliability and compliance.
- Document solutions, including technical specifications, validation protocols, and user guides.
- Provide ongoing technical support and troubleshooting for applications.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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