Influential Woman · Pharmaceutical/Clinical Research
Andrea Arruda
Principal Consultant & Founder, pharmaDev Consulting
Houston, TX 77077
I stopped waiting for permission and started showing up as the most experienced person in the room. Nearly three decades of work doesn't need a disclaimer.
Andrea Arruda · In Her Own Words
Her Story
About Andrea
Andrea Arruda is a clinical research professional with more than 28 years of diverse industry experience across both drug and device research, spanning Phases I–IV and more than a dozen therapeutic areas — including, but not limited to, CNS/Psychiatry, Oncology, Cardiology, Endocrinology, Ophthalmology, Infectious Disease, and Medical Devices.
Her career encompasses 15+ years of CRO and Sponsor-level monitoring experience with globally recognized organizations including Quintiles (now IQVIA), Syneos Health, Pfizer, AbbVie, and PAREXEL, anchored by an equally deep foundation in site-level operations as a Clinical Research Coordinator and Clinic Director. She has built clinical research programs from the ground up on multiple occasions, establishing full operational infrastructure, quality systems, regulatory frameworks, and staff training programs at both site and organizational levels. Her career includes contributions to multiple FDA-approved drug programs, including Auvelity® (2022), Abilify®, and Celebrex®.
In March 2019, Andrea founded pharmaDev Consulting, LLC, based in Houston, TX and Los Angeles, CA, dedicated to bridging the gap between GCP theory and audit-ready site execution. Her consulting services span internal pre-monitoring and quality oversight, site infrastructure development, SOP and ISF/TMF build-out, study start-up, staff training and development, site rescue, and high-complexity monitoring for biotech sponsors across diverse therapeutic landscapes.
Andrea is the creator of the Monitoring Lens™, a practitioner framework for evaluating clinical site work through the same lens a CRA or FDA inspector applies, and the author of The Monitoring Lens™ e-book, a field guide for audit-ready site execution. She is currently developing Mastering Clinical Research™, a 10-module, 36-lesson online training curriculum for Clinical Research Coordinators launching September 2026. Her expertise spans ICH E6(R3) implementation, ALCOA-CCEA documentation standards, investigational product management, and PI oversight under current GCP frameworks.
Above all, Andrea is committed to elevating the clinical research profession — mentoring the next generation of coordinators, training physicians and site staff, and building the kind of field-tested knowledge base that only 28+ years on both sides of the monitoring table can produce.
Her Interview
Ten minutes with Andrea
01What do you attribute your success to?
Being on both sides of the monitoring table. Sitting in the coordinator's seat taught me what sites actually struggle with. Sitting in the CRA's seat taught me exactly what gets flagged. That dual perspective is something you can't manufacture — you have to live it.
02What’s the best career advice you’ve ever received?
'If it isn't written, it didn't happen.' Three decades in clinical research will teach you that documentation isn't paperwork — it's proof. That one principle shaped my entire career and eventually became the foundation of everything pharmaDev Consulting stands for.
03What advice would you give to young women entering your industry?
Master your craft before you worry about your title. In clinical research, your documentation speaks before you do — and a coordinator who knows GCP cold, understands what the monitor is looking for, and owns her role without apology will always outpace someone who chased the ladder instead of the knowledge.
04What are the biggest challenges or opportunities in your field right now?
The biggest challenge is the persistent gap between GCP knowledge and operational execution at clinical research sites — coordinators who know the rules but haven't been taught how a monitor evaluates their work. The biggest opportunity is that this gap is entirely closeable with the right training, the right perspective, and a willingness to look at your own site critically before someone else does.
05What values are most important to you in your work and personal life?
Precision, accountability, and authenticity. I've worked in an industry where a missing signature or an undated entry can derail an entire drug program — that teaches you to take your commitments seriously. Personally, I apply the same standard: say what you mean, do what you say, and own it when you don't.
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