(Associate) Country Study Manager - CVRM
AstraZeneca · Beijing Yizhuang +1 more
Clinical OperationsFull-timeCompany career page
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Role summary
AstraZeneca seeks an Associate Country Study Manager for clinical operations in Beijing and Shanghai to oversee clinical study delivery from protocol through closeout. The role combines study team leadership, regulatory coordination, and local site management to ensure timely, quality study execution.
What they're looking for
- University degree in biological science or healthcare field or equivalent
- Experience leading clinical study teams and managing timelines and budgets
- Knowledge of ICH-GCP guidelines and regulatory submission processes
- Strong project management and stakeholder communication skills
- Proficiency with clinical trial management systems
- Fluency in English and Mandarin Chinese for China-based operations
What you'll be doing
- Lead study team from protocol development through closeout, managing timelines, costs, and quality metrics
- Develop feasibility assessments, recruitment strategies, and contingency risk plans at study and country level
- Coordinate investigator selection, national study meetings, and local regulatory submissions to ethics committees
- Oversee study drug management, adverse event reconciliation, and study master file maintenance
- Support audit preparation, regulatory inspections, and staff training on ICH-GCP compliance
Privacy & handoff
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