Maria Shabe
Sr Director, Clinical Quality Assurance at Rain Oncology
Based in San Francisco, United States
7-day free trial · no credit card
Seniority
Director
Department
Science
Location
San Francisco
Industry
Biotechnology Research
Company size
8
Contact information
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m•••••••@rainoncology.com
Phone
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Background
About Maria Shabe
Clinical research experience in Pharmaceutical, Biotechnology, Medical Device and CRO *Gap analyses of Site, Sponsor and CRO and quality management systems for clinical research *Global quality requirements and global audits experience *GCP/GLP audits including IVRS, EDC providers, CROs, central IRBs, central laboratories, Phase I units, sponsor system-process audits, clinical investigator sites and business partners.*Clinical Development/Operations quality compliance lead (risk evaluation, process improvement and procedure development in clinical trials conduct *Clinical document audits, e.g. CSRs, TMF, Annual Reports, etc *Vendor Management, CAPA and Risk-Evaluation process development *Regulatory agency inspection preparation for Sponsor and Clinical Investigator Sites *GCP training program focused on Clinical, Regulatory and Quality audience.*SOP development for GCP Quality Assurance and Clinical Operations *Clinical trials outsourcing guidelines development
Decision-makers
Other people at Rain Oncology
- CNOther
Chau Nguyen
- () · Other
- SBStaff
Sonia Bhullar
Human Resources Coordinator · Human Resources
- AEDirector
Anita Eshraghi
Director, Clinical Data Management · Research & Development
- MPC-Team
Mehdi Paborji
Senior Vice President · General Business & Management
- SWC-Team
Stefani Wolff
Board Member · General Business & Management
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