Sara Le Lay

AI & automation consultant designing and deploying concrete data tools — RAG chatbots, automated dashboards, workflow automation — for healthcare and life-sciences organizations. With 10+ years leading clinical projects in regulated environments (oncology, rare diseases, GDPR / GCP), I bridge deep domain understanding and hands-on technical delivery. I leverage AI-assisted development and low-code platforms to ship fast, with a focus on measurable impact (KPIs) and compliance.

Clinical Project Manager at Novartis Pharma SAS (2019-10 – 2026-02)

• Led national study strategy with rigorous KPI tracking and optimized resource allocation, aligned with global teams.
• Designed and optimized operational study start-up pipelines, ensuring timeline adherence and EU-CTR / GDPR compliance.
• Deployed standardized processes and reinforced quality controls strengthening data integrity.
• Trained teams and coordinated multidisciplinary, cross-border teams (including a billing unit in India).
• Negotiated study budgets and managed contractual portfolios (CDAs, CTAs, loan agreements).
• Multi-therapeutic expertise: oncology, dermatology, RLT, CAR-T, rare diseases.

Clinical Project Manager at Centre Oscar Lambret (2015-11 – 2019-09)

• Oversaw oncology studies, ensuring operational quality and regulatory compliance across the study lifecycle.
• Led regulatory submissions to French authorities (ANSM, CPP, CNIL).
• Authored and coordinated key study documents: protocols, synopses, informed consent forms, visit reports.
• Trained and supervised field teams (monitoring, data validation, GCP compliance) and managed external vendors (data management, biostatistics).

Machine Learning Engineer in Data science, data engineering, model development and MLOps for scalable ML systems – LIORA (2026-02 – 2026-07)

PhD in Microbiology – INRA / University of Avignon (2011-11 – 2014-12)