Backend Engineer

Project Overview

A site-centric Clinical Trial Management System (CTMS) that helps research sites efficiently activate and manage studies while ensuring full regulatory compliance. The platform streamlines study start-up, documentation, sponsor communication, and operational workflows in an audit-ready environment.

A core component is an AI-powered protocol engine that converts complex clinical trial documents (100–400+ pages) into structured workflows, extracting key elements such as:

• Schedule of Assessments (SoA)
• Visit timelines and structures
• Inclusion/Exclusion criteria
• Investigational product requirements
• Regulatory and operational tasks

Key Responsibilities

• Design and optimize RAG-based pipelines for medical protocol extraction.
• Improve AI performance, traceability, and output validation.
• Build and maintain scalable backend systems (FastAPI, PostgreSQL).
• Model complex clinical data and ensure auditability/compliance.
• Enhance system reliability (logging, monitoring, testing, reproducibility).
• Support system validation (CSV) and enforce secure coding practices.
• Maintain CI/CD pipelines, Dockerized services, and system scalability.

Required Skills & Experience

• 5+ years with Python, FastAPI, SQLAlchemy.
• Strong PostgreSQL expertise (design, performance tuning).
• Experience with microservices, Docker, and async processing (Celery, Redis, RabbitMQ).
• Hands-on experience with RAG systems, LangChain, and vector DBs (pgvector).
• Understanding of LLMs, embeddings, and cost/performance trade-offs.
• Experience in regulated industries (healthcare, fintech, etc.) is a plus.

Nice to Have

• Experience with GxP environments.
• Familiarity with Python tooling (Poetry, Ruff, pre-commit).
• Experience scaling or re-architecting systems.

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