Sean Volpe in

Sean Volpe

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GxP Data and Systems Architect (Consultant) at Cogent | Roche Genentech | Yale (YCCI) | IDEAYA | Atara Bio | Intuitive Surgical | etc.
📍 Brisbane, California, United States

Sean is a GxP Data and Systems Architect specializing in clinical biometrics, bioinformatics, and regulatory data. With a proven record in FDA/EMA submissions and Ai/ML system implementation, he is described by colleagues as detail-oriented, dedicated, and honest. He holds degrees from UNC Charlotte and Southern Connecticut State University.

He was a nominee for the National Collegiate Communication Arts Award.

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Current Role
GxP Data and Systems Architect (Consultant)
Job Level
Middle
Location
Brisbane, California, United States
Personality Overview

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Communication Style
Decision Approach
Work Preference

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Priorities

Topics Sean cares about

Clinical Data Governance
He emphasizes that robust governance, not just advanced analytics, is what keeps clinical studies inspection-ready and scalable, especially when integrating external datasets.
FDA Submission Readiness
He offers expertise in submission readiness audits, legacy data conversion, and compliance with standards like CDISC, SDTM, and ADaM to ensure successful FDA filings.
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Career

Work history

GxP Data and Systems Architect (Consultant)
Cogent | Roche Genentech | Yale (YCCI) | IDEAYA | Atara Bio | Intuitive Surgical | etc.
Sr. Clinical Informatics Analyst
Genentech
Contractor and FTE: Clinical Informatician, CMC Lab Data Manager, Clinical Data Manager
*Pre 2010 Life Sciences Work years*
In the press

Media appearances

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Education
Bachelors Degree
Southern Connecticut State University
Master's degree
University of North Carolina at Charlotte
Social presence
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Behavioral profile

DISC profile (public)

DISC behavioral profile

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