Nine trials, 18 countries, one document system that got 80% faster
01 / Context
End-to-end delivery for 9+ decentralized clinical trials — custom mobile application development for both provisioned and BYOD devices, globally.
One reference program alone, for the largest of the three pharmaceutical clients, ran 4 clinical trials as a single $8M fixed-budget program, 18 countries, 400+ provisioned iOS devices, teams spanning the US, Croatia, Argentina, and Poland.
02 / Problem
Clinical operations teams were searching structured and unstructured data by hand, in a space where getting the answer wrong isn’t an option.
Each trial’s mobile applications needed to be localized and meet trial-specific protocols and compliance requirements — for Fortune 500 pharma clients, in a regulated environment, across multiple time zones.
03 / Approach
Design for the regulated environment first, and treat the platform underneath it as part of the same program.
04 / What I did
Owned design, rollout, and adoption of LLM-powered assistants supporting clinical operations and customer workflows across multiple trial programs.
Contributed directly to model optimization and fine-tuning — structuring training data, refining prompts, and guiding evaluation criteria aligned to clinical and operational use cases. Orchestrated the complete JIRA restructuring that eliminated $200K+ in annual inefficiency.
Role: Sr. Agile Project Manager · Clinical-trial technology company · Nov 2021–Feb 2025 · 18 countries, 400+ devices05 / Outcome
The RAG system cut response time by 80% while holding HIPAA-compliant data handling throughout. The JIRA restructuring paid for itself in visibility as much as dollars — $200K+ in eliminated inefficiency plus improved cross-team visibility across every concurrent trial.
06 / What I would do differently
I’d have built a per-country localization and compliance checklist after the first trial, not relearned the same constraints fresh on every one of the next eight — the pattern repeated more than the plan accounted for.