Shyanne Ali
Aditum Bio
- Role
- Senior Vice President Quality Assurance at Aditum Bio
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Shyanne Ali
Pharmaceutical/Vaccine clinical research professional with in-depth industry experience in areas of compliance,quality risk management, and clinical trial management spanning all phases of drug/vaccine development. Most recent experience being the preparation and implementation of a global compliance program -including but not limited to the area of clinical compliance, deviation and issue management and investigations, health authority prepareness,auditing and monitoring. Proven success in developing, implementing and sustaining robust compliance projects including \"Quality by Design\" approach to clinical data monitoring and risk management planning.
Experience
Senior Vice President Quality Assurance
Apr 2022 — Present
Skills
- Drug Development
- Gcp
- CRO
- Standard Operating Procedure (Sop)
- CRO Management
- U.s. Food and Drug Administration (Fda)
- Clinical Trial Management System (Ctms)
- Ich-Gcp
- Good Clinical Practice (Gcp)
- Management
- Pharmaceutical Industry
- Sop
- Fda
- Biotechnology
- Clinical Research
- Edc
- Ctms
- Electronic Data Capture (Edc)
- Oncology
- Regulatory Submissions
- Clinical Trials
- Clinical Development
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