Clinical Trial Management Specialist
hace 3 semanas
Company Overview: BeiGene is a rapidly growing biotechnology company dedicated to developing innovative cancer therapies.
Job Summary: We are seeking an experienced Clinical Trial Management Associate to support regional clinical study delivery and ensure delegated components of clinical studies are executed per expected quality standards, within timelines and budget.
Key Responsibilities:
- Develops regional study management experience by supporting multiple aspects of clinical trial conduct, including feasibility assessment, study start-up, document generation and review, tracking of samples and enrollment of study participants.
- Acquires solid knowledge of clinical research operations, including interpretation and implementation of regulations/ICH guidelines.
- Supports the setup and logistics of regional team meetings (agenda, minutes, etc.) and establishes good collaboration with key stakeholders regionally and globally.
- Creatures and maintains regional/country level SharePoint folders for the study and regional study team distribution lists.
Essential Functions:
- Creates and maintains regional/country level SharePoint folders for the study and regional study team distribution lists.
- Sets up the countries and sites in the region in appropriate systems (e.g. eTMF, CTMS) and ensures information is kept up-to-date.
- SUPPORTS SYSTEM ACCESS REQUESTS FOR THE REGION/COUNTRY AND ENSURES THESE ARE MANAGED APPROPRIATELY ACROSS THE STUDY LIFE CYCLE, SUPPORTS USER ACCOUNT MANAGEMENT FOR USERS IN REGION.
- May assist in the review of study-related documents as they relate to the supported clinical trials as delegated by the Regional Clinical Study Manager.
Requirements:
- Bachelor's degree or equivalent experience in a related field.
- Minimum 2 years of experience in clinical research or a related field.
- Strong knowledge of clinical trials operations, including interpretation and implementation of regulations/ICH guidelines.
- Excellent communication and project management skills.
Salary: $90,000 - $110,000 per year, depending on experience.
Benefits: Comprehensive benefits package, including medical, dental, vision, and retirement savings plan.
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