Ilea Mathis
Senior Management Level eMBA Clinical Operations / Clinical Trial Professional ACRP-PM / CCRA Certified
- Role
- Senior Manager, Gcp Vendor Quality Management at Vertex Pharmaceuticals
- Location
- Columbus, OH, US
- LinkedIn followers
- 500 followers
Experience
Senior Manager, Gcp Vendor Quality Management
May 2023 — Present
I focus on Clinical Trial Vendor Oversight Quality. I am a Sponsor Oversight & Clinical Trial Vendor Oversight “Fixer” for Clinical Teams. I apply subject matter expert knowledge of clinical trial management and vendor oversight to enforce trial execution requirements and quality standards for clinical trial /clinical development vendor types (EG: eCOA/ePRO, Biostatistics, Consultants, RWE, CRO, Imaging, Laboratory, Phase 1 Units, Home Health / Mobile Research, Translation, Central IRB, Auditing, CTMS, TMF, Medical Writing Regulatory Consulting, Supply Chain, Depots, Transport, Medical Writing, etc). I develop and monitor KPIs/KQIs (key performance/ key quality indicators) and other quality metrics for vendors. I am a negotiator, reviewer and collaborator for contract/MSA and quality agreements. I support front room & back room inspection response & readiness I also contribute to project management & business strategy: due diligence for Mergers, Licensing, Acquisition and Partnership Activities.
Education
Harvard University
AB, Biochemistry
1992 — 1996
University of Massachusetts Amherst
MPH, Public Health Practice
2000 — 2001
Quantic School of Business and Technology
Executive MBA, Business Administration, Management and Operations
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