Responsible for leading Data Management, SAS Programming, Statistical Analysis, and Medical Writing in support of clinical trials. Helping to pioneer and innovate new ingenious solutions for systems (e.g. EDC/eSource etc.) and processes to ensure high quality and project success.

CDISC Standards and Submission Ready DataClinical Trials Data DisclosureGlobalization and Harmonization of OperationsEarly Clinical Development Workflow & Bedside EDCProcess Improvement

Managed global operations for over 120 people across Data Management, Biostatistics, Medical Writing, and Pharmacokinetics.• Developed flexible resourcing model using resources and functions across US, Europe, South Africa, and India.• Led process improvement initiative using Lean Sigma methodology to reduce time by 50% from Last Subject Last Visit to Clinical Study Report.• Supported initiative to produce submission databases for CDISC/SDTM formats.• Played key roles for building a number of customer relationships including serving on three joint customer steering committees.Phase I Data Delivery Services (2009-2011):Directed over 70 people in US and Europe across Data Management, Biostatistics, and Medical Writing functions.• Implemented bedside data capture and processes for management, analysis and reporting on study results.• Led team to implement new operating model for largest customer alliance in Phase I which accounted for over 40% of annual backlog and revenue.• Facilitated further harmonization of systems and processes across Phase I.

Headed Phase I Data Operations to ensure harmonization of systems and processes.• Led strategic initiative to implement automated workflow and electronic data capture across Quintiles Phase I clinics worldwide. • Developed strategy for managing change across Phase I for new processes in both clinic and data management.

Led data management operational activities and for a global staff of over 900 professionals in North America, Europe, India, South Africa, and Australia.• Developed resourcing model to share work across sites to exceed utilization rates of 75%.• Consistently maintained high quality standards with greater than 95% of over 600 active projects meeting quality goals.

Managed all data management activities for Americas including over 500 staff across 7 sites. • Facilitated the re-alignment of Data Management especially in the creation of Therapeutic Lead Roles directly embedded into clinical teams

Managed over 100 staff across data management, programming, CRF design, dictionary coding, and quality control.• Significant impact on customer interaction including steering committees.

Led data management activities including global systems implementation, data delivery architecture and chaired CANDA Core team for electronic submissions.

Managed programming efforts on large CV submission. 1986 – 1987. Lead programmer analyst on numerous CV phase I-IV studies. 1984–1985

Taught Plant Biology, Plant Systematics, Field Biology, and Graduate Studies in Plant Biogeography. Supervised over 15 graduate and undergraduate research assistants.