Amy Wallace
A Clinical Quality & RBQM Professional focused in risk, quality and collaboration
I am a clinical research professional focused on quality, risk-based thinking, and protecting what matters most — participant safety and data integrity.
My work has evolved over the past 20+ years from hands-on clinical research coordination and monitoring into risk-based quality management (RBQM), where I partner with study teams to identify risks early, strengthen oversight, and help ensure studies remain inspection-ready throughout their lifecycle.
Unwilling to hide behind the resume, I'm an energetic motivator, a cheerleader of change, and still very much a fun-loving scientist with a Cheshire-cat smile.
………………………………………………………………………………………………
--> The Particulars <--
.. 20+ years of experience across site, CRO, and sponsor environments
.. Focus on proactive quality oversight and risk-based approaches (RBQM)
.. Strong foundation in clinical operations, monitoring, and study execution
.. Trusted partner to study teams for identifying risks, and mitigation strategies
.. High-touch, collaborative approach to supporting teams and improving outcomes
.. Experienced in regulatory compliance, GCP, and inspection readiness
.. Skilled in developing and enhancing SOPs, processes, and quality tools
.. Proven ability to translate complex data into meaningful insights and actions
.. Strong background across Phase I–III trials in multiple populations and therapeutic areas
.. Passion for mentoring, coaching, and developing teams
………………………………………………………………………………………………
--> Personality/Profile/Strengths Assessments <--
CliftonStrenghts: Developer | Includer | Ideation | Belief | Empathy
Insights Discovery: Helping Supporter - collaborative, values-driven, and focused on supporting people and quality outcomes.
Myers Briggs - INFJ - Advocate
DiSC - Agent Pattern
Buckingham StandOut - Teacher - Pioneer
………………………………………………………………………………………………
I find the most meaning in work that allows me to combine thoughtful problem-solving with collaboration and a focus on prevention.
Behind the curtain, when not saving my corner of the world, I prefer to be wrapped in pristine nature with my book, family and cat.