Sofware Developer - Electronic Data Capture (EDC)

Company Description

Curadel Pharma is an innovator focusing on preventing tumor resistance using disruptive zwitterionic radiopharma technology. The company's platform effectively targets tumor regrowth and resistance while minimizing harm to healthy tissues. Curadel's lead candidate, CPI-003, is a promising targeted alpha therapy for treating challenging rare cancers. Additionally, Curadel is advancing image-guided surgical drugs, with a late-stage drug for ureter imaging currently in a pivotal trial. The company was founded by John V. Frangioni, M.D., Ph.D., a respected pioneer in zwitterionicity and Professor Emeritus at Harvard Medical School.

Role Description

Here at Curadel, we are an innovative Biotech with a clinical trial data management suite built on top of the Microsoft Dataverse. We want to build our own tightly integrated Electronic Data Capture (EDC) module to replace the current CTMS. As a key member of our Software Development Team, the Software Developer will design and build cloud-based applications that streamline our clinical trial operations. This work will help to accelerate the delivery of our therapies to patients by improving data accuracy, regulatory compliance, and operational efficiency.

The Software Developer is responsible for developing, maintaining, and optimizing business applications solutions using APP.NET, Power Apps, Power Automate, and Power BI within the Microsoft 365 ecosystem, ensuring all applications comply with both business needs and regulatory requirements. The Developer collaborates with cross-functional teams to deliver solutions that are efficient, compliant, and scalable, supporting a wide range of business processes while maintaining GxP standards. 

Qualifications

Creating and automating workflows using Power Automate to streamline business processes and/or GxP processes.

Develop scalable backend services using a .NET framework that supports web applications, and seamless integration with Microsoft's Dataverse / SQL.

Supporting SharePoint development, including custom workflows, forms, and site management.

Participating in testing, debugging, and validation of applications to ensure reliability, functionality, and GxP compliance.

Optimize high-performance web applications for data verification, security, and compliance with Clinical Trial regulations including FDA 21 CFR Part 11, HIPPA, and GDPR.

Collaborate with IT Business Analysists, Clinical Operations, Regulatory, and Quality domain experts to deliver impactful features

Write clean, testable code and implement unit tests for continuous integration.

Documenting solutions, including creating technical specifications, validation protocols, and user guides.

Providing ongoing technical support and troubleshooting for applications.

Strong proficiency in ASP.NET, Microsoft Entra AD & Dataverse, and SQL

Working knowledge in Power BI, and Power Apps

Familiarity with clinical operations workflows and terminology

Understanding of GxP regulations and software validation processes

Nice to Have

Hands-on experience with Clinical Operations applications such as Veeva Vault, IQVIA, TrialKit, or Medidata Rave applications.

Background in clinical trials, regulatory affairs, or quality systems