Human-generated
Everything here is written by me. So expect poor grammar and spelling errors at times, though I will do my best.​​
About Me
I grew up alongside modern technology: in college, Google or the modern internet as we know it didn't exist, and almost no one had a cell phone. Now I'm asking ChatGPT how to run my life.
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Professionally, I spent 23 years in clinical R&D. Fourteen of that was working in data management roles, ultimately becoming an Associate Director at a small Pharma. During those 14 years in the industry (early 2000's) there was rapid adoption of software, establishment of CDISC and an industry-wide drive towards smart innovation to improve the efficiency of clinical trials. I loved being on the bleeding edge of these approaches, it was what made clinical research a passion of mine.
The last nine years I was heading operations and data management at AiCure, a disruptive clinical trial technology company. I wore a multitude of hats, occasionally janitorial, but I cherish the firehose of experience. During that time I honed my knowledge and skills related to Quality by Design and Risk-Based Quality Management approaches, even building and managing a team focused on those areas.
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I have a passion for efficiency in research. This can be achieved by creating effective processes that work for the people involved, as well as leveraging the right technology to enable success. And since we work in a highly regulated industry, any innovation also has to be smart and well thought out.
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I hope you find this blog informative, perhaps gaining some takeaways to implement within your organization. Additionally, I can help you with your processes and technology, especially related to QbD and RBQM. Feel free to reach out and I'm happy to chat.​
