Data Scientist.
System Architect.
RBQM Expert.

I started as a Clinical Data Analyst at a leading RBQM technology vendor, learning the fundamentals of central statistical monitoring and risk-based quality management. I worked directly with pharmaceutical sponsors to interpret data anomalies, explain analysis results, and build training materials for RBQM adoption. This was my first exposure to how clinical data actually flows from sites to sponsors, and where the gaps usually appear.

From there, I moved into pharmaceutical research at a major academic medical center, wearing multiple hats: Clinical Research Specialist, Research Project Associate, and eventually System Analyst for Oncology Research. I built databases from scratch, mapped EMR systems to research databases, created data collection workflows, and made sure everything stayed compliant during audits. This is where I learned that good data architecture prevents 90% of quality problems before they even start.

Next, I joined a global EDC and RBQM platform provider as a Senior Implementation Consultant. I gathered requirements, mapped data across CTMS and EDC systems, configured KRIs and QTLs, and trained 75+ users globally on RBQM best practices. This role taught me something critical: technology only works when people actually use it. So I focused on building systems that fit into existing workflows instead of forcing teams to change everything.

After that, I worked as a Business and System Analyst at a pharmaceutical company, where I built and supported a complete RBQM application from end to end. I handled data cleaning, analytics, RACT facilitation, risk management workflows, business process design, and SOP documentation. This was the full lifecycle experience: taking RBQM from concept to production, then keeping it running and improving it based on real user feedback.

I also served as an Operational Advisor for RBQM at a leading CRO, where I created a transformational model to help them adapt new RBQM tools into their existing operations. This meant redesigning monitoring workflows, retraining CRAs and data managers, and proving to leadership that centralized monitoring could actually reduce costs without sacrificing quality. The model worked, and they rolled it out across multiple trials.

Most recently, I was Senior Clinical Data Science Lead at a top-10 global pharmaceutical company, spearheading RBQM strategy for their global oncology program. I deployed standardized KRI/QTL sets, automated weekly Power BI dashboards for governance review, designed RBQM dataflows to integrate clinical and operational databases, and performed statistical monitoring using Central Statistical Monitoring platforms. The goal was simple: detect risks faster, reduce monitoring costs, and keep data quality high.

Throughout my career, I've been a data scientist, system analyst, business analyst, and implementation consultant. I write SQL, Python, and R to build scalable data models. I design Power BI and R Shiny dashboards that turn raw data into something executives can actually use. And I architect data ecosystems that connect disconnected systems (EDC, CTMS, Safety Databases, ePRO) into unified quality engines.

Now, as an independent consultant, I bring that 15+ years of experience to help sponsors implement RBQM that actually works. You can hire me to embed with your team using your existing Medidata, Veeva, or Oracle platforms (staff augmentation), or I can deliver a complete turnkey solution with full documentation and training (solution delivery). Either way, I adapt to your needs.