I have more than 30 years working with for-profit and non-profit organizations to design and implement system solutions to effect organizational change and meet business goals. One major area of expertise is in clinical data standards, where I’ve exceeded Malcolm Gladwell’s 10,000 hours (the “magic number of greatness . . . you need to have practiced . . . for 10,000 hours before you get good.” — Outliers). As a founding board member and original Technical Director of CDISC, I helped establish the organization, started up the foundational teams, and led the effort to create the Study Tabulation Data Model among other products. Most recently, as CDISC CTO from 2012-2015 I introduced new collaboration and standards development tools (Wiki, Issue Tracking, Metadata Repository) and introduced many new capabilities to improve quality, productivity, and credibility. These innovations have helped CDISC achieve significant growth and success since 2012, and CDISC data standards are now required by the US FDA and Japan PMDA.
I have significant experience working with pharmaceutical organizations, CROs, and technology providers, including a successful start-up specializing in data mining and visualization tools for product safety and study data, two of which were adopted by the FDA under CRADAs. I have extensive experience working with clinical operations, pharmacovigilance, data management, statistics, regulatory and quality assurance — introducing what were once new technologies such as EDC, IVR, document imaging, workflow, visualization, data warehousing and analytics — to sponsors, CROs and regulatory authorities.
As of Feb. 2016 I have joined HL7 as their full-time CTO, am thrilled to be in a position where I can try to have a positive influence to advance interoperability within the healthcare ecosystem as well as with clinical research.
You can find out more about me by checking my Linked in profile.
Those who know me recognize my commitment to a strong personal code of values, including:
- Integrity – I stand behind my word
- Transparency – no hidden agendas
- Candor – I call it as I see it
- Creativity – I look for different solutions to common problems
- Pragmatism – I look for solutions that are realistically possible
- Execution – I know how to get things done
- The Value of Time – I abhor wasting anyone’s time, especially my own
- Continuous Improvement – I seek to improve every day.
- Essentialism – plan to do what’s most important, eliminate the noise, focus on simplicity and execution to get the right things done.
Rumors of my retirement are greatly exaggerated.