Giovanni Ortiz
Lead Global Study Manager
- Role
- Sr Mgr Clinical Study Lead at Regeneron
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Giovanni Ortiz
Clinical operations and clinical trial experience with managerial level experience. Directly managing clinical trial budgets, timelines, contracts, vendors and CROs. Extensive knowledge and familiarity with EDC systems, inventory management systems. Clinical Functional Management Oversight – Project Management, Document Control and Technical Writing, Data Management and Clinical Trial Materials Management. IFAPP Academy/Kings College London Medical Affairs in Medicines Development Professional Certification Program (Course completion January 2022)
Experience
Sr Mgr Clinical Study Lead
Sep 2024 — Present · Basking Ridge, NJ, US
Education
Penn State University
Bachelor of Science, Kinesiology
2001 — 2006
Penn State University
Bachelor of Science, Kinesiology, Kinesiology and Exercise Science
2001 — 2006
Skills
- Biotechnology
- Clinical Operations
- 21 Cfr Part 11
- Gmp
- Iso 13485
- Management
- Life Sciences
- Clinical Trials
- Glp
- Medical Writing
- Ich-Gcp
- Clinical Data Management
- Oracle Clinical
- Pharmaceutical Industry
- Sop
- Fda
- Drug Development
- Oncology
- Cancer
- Gcp
- Protocol
- Medical Devices
- Clinical Research
- Capa
- Validation
- Rheumatology
- Clinical Study Design
- CRO
- Medical Affairs
- Edc
- Therapeutic Areas
- Ctms
- R&D
- Regulatory Submissions
- Clinical Development
- Clinical Monitoring
- Process Improvement
- Regulatory Affairs
- Lifesciences
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