Responsibilities Lead delivery of AI‑driven clinical protocol authoring solution. Coordinate requirements, timelines, and dependencies with client stakeholders. Ensure GxP compliance, audit readiness, and regulatory alignment. Oversee Snowflake integration and automation framework setup. Manage reporting, governance, and communication with AZ. Design and implement AI models for clinical protocol authoring (OCR, NLP, LLM pipelines). Develop automation scripts for document ingestion, transformation, and Snowflake integration. Build configurable modules for mandatory vs optional protocol sections. Validate AI‑generated protocol content for accuracy, completeness, and compliance. Skills & Experience 8+ years in QA/AI project management, preferably in Life Sciences. Strong knowledge of GxP, clinical trial processes, and compliance frameworks. Experience with AI workflow orchestration, Snowflake, and automation scripting. Excellent stakeholder management and documentation skills. Design and implement AI models for clinical protocol authoring (OCR, NLP, LLM pipelines). Experience in in AI/ML development (Python, TensorFlow, PyTorch, LangChain) and QA/testing with focus on AI/ML systems.
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