I am a Clinical Data Manager with 20 years of experience working in CRO and sponsor companies. Skilled in working with complex protocols, CRF/eCRF development and implementation, and extensive experience with study build and mid-study changes, development of DM-related processes, and problem-solving with multiple vendors/sponsors to meet goals and deadlines. Proficient at maintaining data quality and integrity by monitoring data collection, query resolution, and data cleaning throughout the clinical trial life cycle to support analyses and regulatory submissions.

I am a highly-skilled, motivated professional with over 33 years of experience in Biostatistics and Data Management and the last 30 years in the biotech/CRO industry. I have experience in various clinical indications specializing in oncology, dental anesthetics and cavity reduction, pain, GI, Lupus, and infectious disease. I have extensive experience working with the FDA, directly involved in eight successful (approved) NDAs, sNDAs, and BLA submissions. I have twice built the entire data management, programming, and statistical department from the ground up (computer network system, integrating data management software (paper and EDC), SAS programming, biostatistics, SOP development, etc.). I have exceptional interpersonal, communication, and managerial skills, having supervised biostatisticians, SAS programmers, data management, I.T., and medical writing personnel. I am comfortable multi-tasking with senior executives, M.D.s, R&D, and regulatory personnel in a fast-paced, dynamic environment.

I am a board-certified toxicologist with over 15 years of experience in small molecule pharmaceutical development. I have extensive experience monitoring and conducting non-GLP and GLP studies from early IND stage projects through registration studies, including reproductive and development studies. I have worked extensively with developing injectable drug products and oral formulations with Scheduled compounds. I have worked with the FDA and numerous health authorities worldwide, including TGA, Health Canada, MHRA, ANSM, BfArM, and EMEA. I have authored, co-authored, and reviewed INDs, CTAs, IB, NDAs, Annual Reports, and DSURs/PBERS.

I am an executive-level Clinical Operations Leader with over 20 years of experience in the pharmaceutical and biotech industry. I began my career in drug discovery as an in vivo pharmacologist characterizing compounds for gastrointestinal disorders and neuroscience and pain and related disorders indications. I have authored over 15 papers, reviewed INDs, protocols, IBs, and CSRs, and was a voting member of IACUC committees. I successfully transitioned into clinical development leading global oncology trials for CROs and a Fortune 500 company. In addition, I successfully led a global Phase 2 oncology trial achieving breakthrough therapy designation. Cross-functional leadership (CMC, Regulatory, Data Management, Stats/Programming, Quality, Biomarker, Pre-clinical, Country managers, Contracts/Budgets) of oncology clinical trials and clinical programs is my expertise, successfully leading the lifecycle of global trials, managing global trial leaders, and lending the clinical and operational voice to drive the strategy and successful execution of corporate objectives.

I am a Biostatistics professor, a Settle-based cancer research center member, and a former Director of the Statistical Center for HIV/AIDS at the National Institutes of Allergy and Infectious Diseases Prevention Trial Network. I have authored or coauthored several books and more than 250 research articles in peer-reviewed journals, many regarding the development of state-of-the-art methods for the design, conduct, and analysis of clinical trials, and many others reporting the results of landmark trials, including a NEJM publication on the prevention of HIV transmission. This research, on which I was senior author, was recognized by Science Magazine as a scientific “Breakthrough of the Year.” I was the former Chair of Biostatistics at a Seattle-based university. I have chaired or served on Data Monitoring Committees for over 100 clinical trials. In addition, I serve as a Special Government Employee for the FDA. For over 25 years, I have been a regular member of FDA Advisory Committees and an invited voting member on over 100 occasions. I am also a member of the Institute of Medicine of the National Academies.

I am an executive level Clinical Data Manager with 20+ years of unique, hands-on, 'in the weeds' experience working in all phases of studies and within all states of a study, from start-up to close/lock, pharmacologic, biologic, as well as a medical device and diagnostic clinical trials. I have experience working on the side of both large and small pharma/med devices as well as large and small CROs. I can serve as your comprehensive data management subject matter expert for end-to-end delivery of data management services. My therapeutic area experience spans a large range, with a recent focus on oncology and rare disease. I'm very well versed in widely used (and some not so widely used) EDC systems with a system designer certification in several.