Celeste N R.

About Celeste N R.

Experienced Clinical Trial Manager with a demonstrated history of working in the Hematology Oncology clinical trial space. Skilled in Microsoft Office, Clinical Data Management, Cancer Research, People Management, Healthcare Management, and CRO/Third vendor Management. Strong healthcare services professional with a Master’s Degree focused in Bioethics/Medical Ethics from Columbia University in the City of New York.

Experience

1. Local Study Associate Director

   AstraZeneca

   Feb 2025 — Present

   Lead Local Study Teams (LSTs) at the country level to deliver clinical studies according to agreed resources, budget, and timelines-Ensure compliance with AZ Procedural Documents, ICH-GCP, and local regulations throughout the study lifecycle-Coordinate the site selection process by identifying potential sites/investigators and conducting Site Qualification Visits-Ensure timely submission of application/documents to Ethics Committees/Institutional Review Boards (EC/IRB) and Regulatory Authorities-Manage the financial aspects of the study, including the preparation of Study Management Agreements and maintaining accurate budgets-Collect and verify all essential trial documents required by ICH-GCP prior to study start-Plan and coordinate local drug activities, including purchase, reimbursement, and destruction of drugs-Set up and maintain the study in the Clinical Trial Management System (CTMS) and local websites as required-Oversee monitoring activities from site activation through to study closure, ensuring adherence to Monitoring Plans -Proactively identify risks and facilitate the resolution of complex study problems

Education

• Hunter College

  Certificate, Post Baccalaureate Health Science Program

• Fordham University

  Bachelor of Science (B.S.), International Business

• Columbia University

  Master’s Degree, Bioethics/Medical Ethics

Skills

• Clinical Research
• Medical Research
• Spanish
• Hematology
• Biochemistry
• Regulatory Affairs
• Budgets
• Community Outreach
• Volunteering
• Patient Safety
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Employee Training
• Edc
• Clinical Data Management
• Compliance
• Outlook
• Infectious Diseases
• Clinical Development
• Research
• Peer Support
• Institutional Review Board (Irb)
• Oncology
• Protocol
• Online Research
• Laboratory Skills
• Microsoft Word
• Interpersonal Skill
• Tutoring
• Regulatory Submissions
• Cancer Research
• Leadership
• Irb
• CRO
• Literature Reviews
• Healthcare Management
• Cancer
• Gcp
• Microsoft Office
• Data Management