Clinical Trial Manager at ICON managing trial operations, ensuring high - quality outcomes and compliance with trial protocols for clinical development in Beijing and Shanghai.
About the role
- Senior Manager managing clinical science projects within Regeneron Genetics Medicine. Overseeing clinical trials and contributing to regulatory documentation and compliance.
Responsibilities
- Supports the cross-functional study team on various activities
- Contributes to the writing of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs)
- Assists with identifying collaborators/advisors and organizes consultations
- Represents the clinical function on clinical study teams
- Works alongside Clinical Trial Manager for day-to-day clinical input
- Drafts clinical sections in regulatory and clinical documents
- Reviews study related documents
- Trains and supports study team and CRO personnel
- Assists with medical monitoring and writing safety narratives
- Organizes steering committees, advisory boards, and data safety monitoring boards
- Identifies program or data risks and implements strategies
- Ensures compliance with guidelines for clinical safety
- Provides background literature searches in support of clinical strategy
Requirements
- Bachelor’s degree
- Ph.D., PharmD. or Master’s degree in biomedical subject
- 8 years of clinical research/development experience
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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