Senior Software Engineer, Clinical Trials Platform (Python)

Salary: $125,000 - 160,000 per yearRequirements:

• At least 5 years of professional software engineering experience, including production ownership of a web application.
• Strong Python, Django, Django REST Framework, Django ORM, and versioned migration skills.
• Experience with PostgreSQL schema design, migrations, constraints, and query performance.
• Angular and TypeScript experience, including components, services, routing, HTTP interceptors, and RxJS.
• Experience with AWS services such as ECS Fargate, RDS, IAM, Secrets Manager, and CloudWatch; Docker; and infrastructure as code using AWS CDK with TypeScript.
• Knowledge of REST API design, OAuth 2.0, JWT authentication, role-based access control, and multitenant SaaS patterns.
• Experience with automated testing across the stack, CI/CD, and Git-based pull request reviews.
• Experience building and operating software that stores protected health information under HIPAA.
• Working knowledge of 21 CFR Part 11 and Good Clinical Practice, or equivalent experience with GxP or other FDA-regulated software.
• Experience building rules or decision logic with explainable, versioned, and auditable outputs.
• Strong technical writing skills for regulated documentation.
• Preferred: experience with clinical trial or decentralized clinical trial software, such as EDC, eConsent, eCOA/ePRO, CTMS, IRT, or recruitment platforms.
• Preferred: hands-on validation work, including IQ/OQ/PQ, CSV, or CSA, and audit or inspection support.
• Preferred: familiarity with CDISC standards, including CDASH and SDTM, and awareness of ODM and ADaM.
• Preferred: familiarity with HL7 FHIR R4, US Core data mapping, telehealth or video visits, and WCAG 2.1 AA accessibility.
• Preferred: experience with LLM-assisted extraction of criteria from protocols and records, with human review.
• Preferred: familiarity with autism assessment instruments such as ADOS-2, ADI-R, and Vineland-3.
• Preferred: SOC 2 Type II audit support, AWS Associate-level certification, or GAMP/CSV training.
• Within 30 days of starting, complete ICH E6(R3) GCP training, Human Subjects Research training, and our HIPAA training.

Responsibilities:

• Design and deliver full-stack features using Python, Django, Django REST Framework, Angular, TypeScript, and PostgreSQL on AWS, with infrastructure defined in AWS CDK.
• Develop online prescreening questionnaires, consent-to-contact registries, and a versioned, protocol-driven eligibility rules engine with explainable results linked to evidence.
• Create eConsent and assent workflows with version-controlled, IRB-approved materials, identity verification, comprehension checks, and Part 11-compliant electronic signatures.