Senior Software Engineer, Clinical Trials Platform (Python, Django, Angular)

Job Overview

Meadow Health is a 50 state telehealth practice providing precision care for neurodevelopmental conditions. We run our own multitenant care platform and are extending it to support decentralized clinical trials, from remote recruitment and prescreening through eConsent, remote visits, ePRO, data capture and sponsor reporting.

We are seeking a Senior Software Engineer to build these capabilities hands on, end to end, in Python, Django, Angular, PostgreSQL and AWS CDK. This role sits at the intersection of engineering and clinical research: you will build, validate and document software that will be inspected under FDA 21 CFR Part 11, ICH E6(R3) Good Clinical Practice, IRB and HIPAA expectations. The screening tools you build flag, explain and document, while investigators and clinicians make the decisions. You will report to the CEO and have early ownership of the clinical research architecture of a platform used in real patient care.

Duties

• Design and ship features across the stack in Python, Django and Django REST Framework, Angular and TypeScript, and PostgreSQL, running on AWS with infrastructure defined in AWS CDK.
• Build online prescreen questionnaires, consent to contact registries and a versioned, protocol driven inclusion and exclusion rules engine whose results ("likely met," "likely not met," "needs review") are explainable and linked to evidence.
• Build eConsent and assent workflows with version control of IRB approved materials, identity verification, comprehension checks and Part 11 compliant electronic signatures.
• Support remote and telehealth study visits, scheduling and reminders, and ePRO and eCOA questionnaires for participants and caregivers.
• Build electronic case report forms with edit checks, query management, data review and locking, and complete audit trails.
• Implement Part 11 controls, including time stamped audit trails, electronic signatures, role based access, record retention and human readable exports.
• Produce risk based validation evidence (CSV and CSA, IQ/OQ/PQ, traceability, test scripts and release records) in line with GAMP 5, backed by automated tests across the stack (Django unit and API tests, Angular unit tests, Playwright end to end tests).
• Build secure, reliable integrations with sponsor, CRO and site systems (EDC, CTMS, lab and rater data) and sponsor reporting such as enrollment funnels, screen fail reasons and data completeness.
• Keep each study and the clinical care program strictly separate in the data model, authorization and queries.
• Protect PHI under HIPAA with encryption in transit and at rest, managed secrets, least privilege access and access logging, and contribute to controls aligned with NIST CSF and SOC 2.
• Write and maintain data models, API and data flow documentation, and system descriptions for IRB submissions, sponsor audits and regulatory inspections.
• Work closely with clinicians, research and operations staff to translate protocol requirements into clear specifications and working software.

Skills

• 5+ years of professional software engineering with production ownership of a web application.
• Strong Python, Django and Django REST Framework, including the Django ORM and versioned migrations.
• PostgreSQL schema design, migrations, constraints and query performance.
• Angular with TypeScript (components, services, routing, HTTP interceptors) and RxJS.
• AWS (ECS Fargate, RDS, IAM, Secrets Manager, CloudWatch), Docker, and infrastructure as code with AWS CDK in TypeScript.
• REST API design, OAuth 2.0 and JWT authentication, role based access control and multitenant SaaS patterns.
• Automated testing across the stack, CI/CD, and Git with pull request based code review.
• Experience building and running software that stores PHI under HIPAA.
• Working knowledge of 21 CFR Part 11 and GCP, or equivalent experience building GxP or other FDA regulated software.
• Experience building rules or decision logic whose outputs are explainable, versioned and auditable.
• Clear technical writing for regulated documentation.

Preferred

• Software for clinical trials or DCTs (EDC, eConsent, eCOA/ePRO, CTMS, IRT or recruitment platforms).
• Hands on validation work (IQ/OQ/PQ, CSV and CSA) and audit or inspection support.
• CDISC standards (CDASH and SDTM; ODM and ADaM awareness).
• HL7 FHIR R4 and US Core data mapping.
• Telehealth or video visit experiences and WCAG 2.1 AA accessibility.
• LLM assisted extraction of criteria from protocols and records, with human review.
• Familiarity with autism assessment instruments such as ADOS 2, ADI R and Vineland 3.
• SOC 2 Type II audit support, AWS Associate level certification, or GAMP/CSV training.

Required within 30 days of start: ICH E6(R3) GCP training (for example CITI GCP), Human Subjects Research training and Meadow HIPAA training.

We offer a competitive salary and equity, and meaningful work that improves care and research access for autistic children and their families.

Meadow Health is an equal opportunity employer.

Pay: $125,000.00 - $160,000.00 per year

Work Location: Remote