Clinical Systems QA & Validation | Medidata Rave EDC | CSV · GxP · 21 CFR Part 11 · CDISC
Intro
I am a clinical systems QA and validation professional with 20+ years across electronic data capture, clinical data management, and regulated SaaS. I started at Medidata Solutions in 2002, where I led a team of 11 specialists and configured 100+ clinical studies on Medidata Rave, and later returned as an Implementation Consultant on FDA-regulated trials, training 50+ client teams on the Rave suite. Most recently I spent two years as a QA consultant in clinical trial technology, building validation plans and test strategies and managing customer UAT across the eCRF development lifecycle — under FDA, ICH, 21 CFR Part 11, and CDISC (CDASH/SDTM).
For the last two years I have run Datum Pie LLC, a small software company where I specified, tested, and verified a multi-product SaaS platform built end to end by AI coding agents. I wrote the acceptance criteria, built the regression coverage, and signed off on what was — and was not — actually proven.
Validating software I did not write by hand
I work with AI as the primary implementation tool: I write the spec, direct the implementation, review every change, and test what ships. On my own platform that produced a 206-test automated regression suite, verified role-based access control and multi-tenant row-level data isolation, and a written readiness assessment that documented exactly which integration paths were verified versus assumed — and blocked release on the ones that were not.
That maps directly onto where regulated industries are heading: GAMP 5 (2nd edition) AI/ML guidance, Computer Software Assurance, and the open question of how to validate AI-enabled systems under FDA scrutiny. Very few QA people have done it hands-on, daily, for two years.
Available immediately for contract, contract-to-hire, or full-time work in computer system validation, GxP QA, or clinical systems — remote or Reno/Sparks, NV.
Multi-product SaaS platform built end to end using AI coding agents, with the founder acting as specifier, test author, and verifier of all machine-generated output.
Responsible for specification, test authorship, and verification across a multi-repository production codebase generated by AI agents.
Performed hands-on validation of AI-generated software: authored functional specifications and acceptance criteria, evaluated agent output against specification, and iterated to closure on defects.
Built and maintained a 206-test automated backend regression suite plus production build verification, establishing repeatable release gating for every change.
Verified role-based access control (RBAC) and multi-tenant row-level data isolation, including negative testing for cross-tenant data leakage.
Authored a code-grounded release readiness assessment with explicit pass/fail criteria, documenting which integration paths were verified versus assumed and formally blocking release on unproven billing, SMS, and email workflows.
Established data integrity and lineage controls across a 9,200-record dataset with source attribution on every record, plus a written source-licensing governance framework.
Computer System ValidationTest AutomationData IntegrityAI-Enabled Software QA
Akyrian Systems, New York, NY (Remote)
QA & Compliance ConsultantSeptember 2022 – June 2024
Akyrian Systems specializes in clinical trial technology, focusing on source document extraction and compliance for pharmaceutical and healthcare companies.
Responsible for testing software applications and ensuring compliance with design specifications and regulatory standards throughout the clinical trial eCRF development lifecycle.
Spearheaded end-to-end testing efforts, conducting comprehensive software evaluations to identify bugs before release and delivering actionable insight reports.
Developed robust validation plans to uphold regulatory compliance (FDA, ICH, CDISC, CDASH, SDTM) and quality assurance benchmarks across products.
Facilitated formal requirements gathering, development, and testing sessions, ensuring alignment with project scope and complexity.
Managed customer UAT activities, leveraging interactive sessions to implement real-time fixes and foster a transparent, collaborative environment.
Quality AssuranceRegulatory ComplianceHealthcare IT
Affirma Consulting, Reno, NV (Remote)
Data AnalystJanuary 2022 – June 2022
Affirma Consulting provides technology and data-driven solutions, including business intelligence and customer engagement strategies.
Supported accurate evaluation of ongoing processes and facilitated sound decision-making regarding future initiatives by developing Excel reports and a Power BI dashboard of quarterly financial incentives data for MSFT executive oversight.
Conducted SQL-based data analysis on datasets exceeding 1 billion records, ensuring compliance for $100M+ in quarterly financial incentives.
Designed automated Power BI dashboards to enhance business intelligence and executive decision-making, reducing reporting time by 90%.
Recommended Azure query optimization strategies, improving overall data architecture and reducing server costs.
Collaborated with the Licensing & Revenue Management team to align incentive workflows with business operations.
Data AnalysisSQLPower BIBusiness Intelligence
SK Baseball - Reno Aces, Reno, NV
Analytics CoordinatorMay 2021 – November 2021
The Reno Aces are a professional minor league baseball team focused on delivering a top-tier fan experience and data-driven operational strategies.
Provided support for ticketing operations during game days, ensuring smooth transactions, and assisted with data collection and reporting to improve visibility for management.
Conducted data mining on 250,000+ customer records to identify qualified leads and increase sales.
Developed predictive models for ticket sales using statistical analysis to enhance operational efficiency.
Created Power Pivot dashboards for data visualization, improving decision-making for sales and marketing teams while supporting targeted campaigns to improve ROI.
Data MiningPredictive ModelingData Visualization
Pitney Bowes, Sparks, NV
Operations Lead, Quality AssuranceMay 2020 – April 2021
Pitney Bowes is a leader in logistics, mailing, and data management solutions, serving businesses worldwide.
Maintained quality control by serving as part of a team to complete periodic quality audits for five departments in the facility, generating daily, weekly, and monthly tracking reports.
Conducted periodic quality audits across five facility departments, implementing process improvements that directly reduced errors.
Designed and delivered performance tracking reports using Power BI and Excel, significantly improving data accuracy.
Analyzed and resolved over 20 daily Jira tickets, utilizing root cause analysis to mitigate and prevent future risks.
Devised risk mitigation strategies and developed inspection procedures to ensure adherence to quality standards.
Quality AssuranceProcess ImprovementRoot Cause Analysis
CFI Holdings, LLC – Saffron Café & Bakery, Clackamas, OR
OwnerOctober 2013 – December 2017
Saffron Café & Bakery was a locally owned business specializing in handcrafted baked goods and creating a welcoming community atmosphere.
As the sole owner, I managed all aspects of the business, combining hands-on operational work with strategic management to create a successful customer-focused operation.
Managed all facets of the business, combining hands-on operations (baking, customer service, inventory, vendor negotiations) with strategic management.
Improved operational efficiency by implementing workflow enhancements, optimizing inventory controls, and reducing waste by 20%.
Built a loyal customer base by providing high-quality baked goods and exceptional service, increasing repeat business and profitability.
Medidata Solutions provides industry-leading SaaS platforms for clinical trial data management and analytics.
Acted as a liaison between project teams and clients to deliver on key timelines, configure data systems, ensure compliance, and optimize study outputs.
Implementation Consultant (2012–2013): Led FDA-regulated clinical trial projects, ensuring data integrity and regulatory compliance. Trained 50+ client teams — sponsors and clinical study sites — on the Medidata Rave suite of products. Designed study-specific configurations and performed root cause analysis in coordination with customer care and IT.
Project Analyst (2006): Translated client needs into actionable system functionality specifications for seamless implementation and tracked project deliverables.
eCDM Specialist / Team Lead, Data Outputs (2002–2005): Supervised a team of 11 specialists. Configured 100+ clinical studies using Medidata Rave, authored dataset specifications, and developed and validated output tables using SQL Server, SAS, and Rave. Established data extraction workflows that reduced errors by 25%.
Medidata RaveElectronic Data Capture (EDC)Clinical Data ManagementSAS / SQL Server
Bach International, LLC, East Rutherford, NJ
OwnerDecember 2007 – October 2011
Importer of luxury silk products and accessories from India.
Managed operations, vendor relations, and sales strategies to expand market share and optimize logistics.
Negotiated vendor contracts for luxury imported goods, reducing costs and lead times by 10%.
Increased customer base by 15% through strategic marketing initiatives and sales campaigns.
Developed data-driven performance dashboards using Excel macros and pivot tables to improve decision-making and streamline inventory management.
Supply Chain ManagementPerformance Tracking
Madrona Solutions, Seattle, WA
Senior ConsultantNovember 2006 – September 2007
A consulting firm specializing in CRM-integrated solutions for business process optimization.
Designed and implemented CRM solutions tailored to client requirements.
Designed, customized, and implemented Microsoft CRM solutions tailored to client requirements, enhancing process efficiency and user adoption.
Performed system testing, wrote validation scripts to ensure scalability, and authored training materials for end-user onboarding.
CRM (Dynamics 365)System Testing
Portfolio
Analytical projects and working software, each with a documented business case, a reproducible surface, stated limitations, and a passing test suite — plus the two entities I operate under.
Companies
Datum Pie LLCNevada holding companyNevada company through which I build and test my own software. The platform behind it is where the AI-generated-code validation work described above was done.Visit datumpiellc.com
Stackend Solutions LLCOperating software consultancyThe consultancy entity I work through on outside engagements — QA, validation, automation, and contract engineering.Visit stackendsolutions.com
Data Analytics Projects
Each project follows the same standard I apply to regulated software: a documented business case, a reproducible analysis, explicitly stated limitations, and a passing automated test suite — enough methodology that someone else can evaluate the thinking rather than take it on faith.
The Diamond Road Trip OptimizerPython · Live MLB Stats API · SQLite · Power BIGive it a list of teams, a date window, and a starting city. It pulls the live MLB schedule, matches each game to real stadium coordinates, and builds a distance-optimized road-trip itinerary — flagging any team that can't be reached in time instead of silently dropping it.
The True Breakfast Commodity IndexPython · Live FRED API · pandas · SQLite · Power BIPulls live historical retail prices for six breakfast staples straight from the Federal Reserve's own data system and builds a weighted composite index — benchmarked against Headline and Core CPI — so a single volatile ingredient (like eggs) can't distort the real inflation story.
Bark in the Park Concession OptimizerPython · NumPy · SQLite · SQL · Power BIA statistical proxy model answering a question real point-of-sale data never reveals to outsiders: does a dog-friendly stadium promotion's incremental concession revenue actually cover its added cleaning cost? Simulates a full 81-game season and finds the answer is yes — by a wide margin, driven by a shift toward high-margin specialty items.
I have spent 20+ years in clinical systems QA and validation — electronic data capture, clinical data management, and regulated SaaS. I started at Medidata Solutions in 2002 as an eCDM specialist and team lead, returned later as an implementation consultant on FDA-regulated trials, and most recently spent two years consulting on validation for a clinical trial technology company serving pharmaceutical clients.
For the last two years I ran a small software company of my own, where the work was almost entirely specification, testing, and verification of software generated by AI agents. That turned out to be the most current thing I have done: regulated industries are working through exactly this problem right now under GAMP 5 (2nd edition) AI/ML guidance and Computer Software Assurance, and very few QA people have done it hands-on, daily, for two years.
What I actually do, in one sentence: decide whether a system does what it was specified to do, and write down precisely what has and has not been proven.
I studied Finance and Operations Management at UMass Amherst. My toolkit includes SQL, SQL Server, SAS, Power BI, and Python, alongside 21 CFR Part 11, ICH, GxP, and CDISC (CDASH/SDTM).
Outside of work I'm usually walking or hiking with my dog, Maverick, testing a new recipe, or finding unforgettable meals at restaurants throughout the area.
Available immediately for contract, contract-to-hire, or full-time work in computer system validation, GxP QA, or clinical systems — remote or Reno/Sparks, NV. Feel free to reach out.
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