Edgar Belsom

About Edgar Belsom

For more than 20 years, I have been the person organizations trust to keep their clinical…

Experience

1. Manager, Medidata Administrator

   Nanobiotix

   Jan 2021 — Present · New York, NY, US

   Create and manage study specific TMFs • Wrote the initial UAT for the implementation of the Medidata eTMF• Manage all upgrades and perform all System Administration responsibilities (UAT and System analysis for periodic improvements). • User Account Management, maintenance of system libraries and periodical system audits• Work with the Clinical Study Teams, leading the operational management of the CTMS and the Trial Master File (TMF).• Act as a liaison between end-user groups using the system and the system developer.• Lead the development of the CTMS User Training Plan and execute the plan after implementation (internal and external).• Create and Update eTMF & CTMS Work Instructions.• Collaborate with vendor on the ongoing CTMS system issues, upgrades, and maintenance.• Create and communicate reports, updates/issues to stakeholders on a scheduled or necessary basis.• Work directly with the Clinical Study Teams, leading the operational management of the CTMS and the Trial Master File (TMF) with a focus on inspection readiness.• Act as Medidata Subject Master Expert (SME).

Education

• Louisiana State University

  Master of Library & Information Science (M.L.I.S.)

• Louisiana State University

  Bachelor of Arts (B.A.)

Skills

• Ich-Gcp
• Document Management
• End User Training
• Clinical Development
• Customer Service
• Project Management
• Clinical Research
• Drug Development
• Trial Master File
• Gcp
• Clinical Data Management
• Adobe Acrobat
• Pharmaceutical Industry
• Quality Assurance
• Life Sciences
• Edc
• Ctms
• Resume Writing
• Microsoft Word
• Good Clinical Practice (Gcp)
• CRO Management
• Vendor Management
• Tmf
• Clinical Trial Management System (Ctms)
• Process Improvement
• Clinical Trials
• Microsoft Excel
• Powerpoint
• Research
• Data Management
• Microsoft Office
• Electronic Data Capture (Edc)
• Associate Development