John L.
Clinical Data Lead | Clinical Data Management | Clinical Project Management | I help your EDC system get ready for push to Go-LIVE| If you have Post PRODUCTION changes and are concerned about the DB ☝🏾
- Role
- Senior Manager, Clinical Database Development at Amencefs - Cro
- Location
- Staten Island, NY, US
- LinkedIn followers
- 500 followers
About John L.
Senior Clinical Systems and EDC Programming leader with deep expertise designing, building, validating, and governing Medidata Rave EDC and integrated clinical data systems across global biopharmaceutical, CRO, and vendor environments. 10+ years of progressive responsibility spanning hands‑on database programming, global library development, system administration, vendor oversight, and cross‑functional leadership. Adept at architecting inspection‑ready clinical databases, developing enterprise standards, and managing complex system lifecycles including upgrades, integrations, and automated safety reporting modalities. Experienced in leading and mentoring clinical database developers and system administrators, establishing governance frameworks, and driving continuous improvement across GxP‑regulated environments. Offers advanced proficiency in Medidata Rave (EDC, Coder, Lab Admin, Safety Gateway), Veeva Clinical Vault, CTMS, and modern EDC platforms, with experience in C#, SQL, and CDISC/CDASH/SDTM and ADaM standards. A trusted SME who partners seamlessly with Data Management, Clinical Operations, Biometrics, and Quality to optimize digital clinical ecosystems and enhance operational efficiency.
Experience
Senior Manager, Clinical Database Development
Sep 2023 — Present
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