Senior Software Engineer, Clinical Trials Platform (Python)

Requirements: 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. Support remote and telehealth study visits, scheduling, reminders, and ePRO/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 timestamped audit trails, electronic signatures, role-based access, record retention, and human-readable exports. Produce risk-based validation evidence, including CSV and CSA materials, IQ/OQ/PQ, traceability, test scripts, and release records aligned with GAMP 5; support this work with automated tests across the stack. Develop secure, reliable integrations with sponsor, CRO, and site systems, including EDC, CTMS, laboratory, and rater data, as well as sponsor reporting on enrollment, screen-fail reasons, and data completeness. Keep study data and the clinical care program strictly separated in the data model, authorization, and queries. Protect PHI through encryption in transit and at rest, managed secrets, least-privilege access, and access logging; 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. Collaborate with clinicians and research and operations staff to turn protocol requirements into clear specifications and working software.

Technologies: APIAWSAngularCI/CDCloudWatchDjangoDockerFlowGCPGitHTTPHL7IAMSupportJWTLLMOAuthPostgreSQLPythonRESTRxJsTypeScriptWebCloudPlaywright More: We are Meadow Health, a 50-state telehealth practice providing precision care for neurodevelopmental conditions. We operate our own multitenant care platform and are expanding it to support decentralized clinical trials, from remote recruitment and prescreening through eConsent, remote visits, ePRO, data capture, and sponsor reporting. As our Senior Software Engineer, you will build and document software at the intersection of engineering and clinical research, with screening tools that flag and explain results while investigators and clinicians make decisions. You will report to our CEO and take early ownership of the clinical research architecture for a platform used in real patient care. We offer competitive salary and equity, along with meaningful work to improve care and research access for autistic children and their families. Compensation is $125,000–$160,000 per year, and the position is remote. We are an equal opportunity employer. last updated 42 week of 2026