Dynamic and multi-faceted Clinical Trial Innovator with a broad spectrum of Cross-Functional/Therapeutic/Phase experience, working at 4 Big Pharma Companies in the last 20 years. Domain expert in R&D Optimization via Data, Technology & Process Simplification, supporting the operational delivery of thousands of Trials from feasibility/site selection to recruitment planning/tracking to instream monitoring, resource management and risk evaluation to leading health authority inspections and portfolio evaluation. Ground-breaking pioneer who has infused an evidence based analytical culture, launching >50 industry-first decision support platforms to >20,000 users in Drug Development. Innate ability to bridge business challenges with IT innovations and dissect broken outdated processes, delivering automation, re-engineering and change strategy (Lean Sigma Black Belt). Has supported hundreds of Trials Teams from Start-up to Conduct to Closure at the Global, Country & Site Level working across boundaries with Trial Mgmt, Monitoring, Data Mgmt, Stats, Report Writing, Vendor Mgmt, Drug Supply, Safety and Regulatory. Quality First Mindset serving in QA Leadership roles bringing a new age data driven approach to ensure in-stream inspection readiness and risk detection/mgmt. Unique Blend of Deep business acumen, Data/Technology/Process prowess, Eye for Quality, Executive communications skills and an Innovative/Outside the Box Thinker. Rare, Well Rounded Leader, with great depth, breadth and agility, wearing many hats, each successfully with tenacity and curiosity. High Achiever personality and work ethic, with forward looking vision and flawless execution to transform units and disciplines into the Industry “Gold Standard. Functional Expertise:(1) R&D/Trial Operations & Optimization(2) Advanced Analytics (Descriptive, Predictive, Prescriptive), Big Data, Machine Learning(3) Metrics, Scorecards, Dashboards, KPIs/KRIs/KQIs(4) IT System Design & Delivery / Business Intelligence Solutions(5) Quality Assurance, GCP Compliance, HA Inspections(6) Process Excellence (Black Belt)(7) Resource Algorithms, Forecasting & Maximization(8) Innovation / Transformation / Change Mgmt(9) Strategy & Operations(10) Risk & Issue Detection/Mgmt/Registers(11) Project & Portofolio Mgmt/Analysis(12) Site Selection/Recruitment Planning/Tracking/RBM(13) Finance & Accounting(14) Competitive Intelligence / Benchmarking(15) Operational Effectiveness(16) Training & Capability Development(17) Organizational Design & Deployment(18) Communications (Verbal/Written)