Sr. Medical Monitor Manager
Emerald Clinical · Nzalae/ Nzawa locations
Job description
职位概况
负责临床试验的医学监督与支持，确保研究安全、合规、科学开展，作为高级医学联系人参与方案设计、医学评审及安全评估。
主要职责
- 审阅并提供医学意见于方案、知情同意书、研究手册、统计分析计划等文件。
- 参与试验启动、监查、关闭等关键环节，为监查员和项目团队提供医学培训与支持。
- 对临床数据进行医学审查，识别质量或安全问题并提出整改建议。
- 评估并处理不良事件（AE/SAE），完成医学判定、因果评估及随访建议，撰写或审阅医学报告。
- 与研究中心、申办方、安全监查委员会、药物警戒团队及监管部门就医学事项沟通。
任职要求
- 具备医学或相关专业背景，拥有临床研究经验。
- 熟悉GCP规范及临床试验流程。
- 能够独立进行医学审查、风险评估和安全管理。
- 具备良好的跨团队沟通协调能力。
必备技能
- GCP合规知识
- 医学审查与安全评估能力
- 临床数据分析基础
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Published 3 weeks ago
Expires 1 month from now
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Emerald Clinical
Nzalae/ Nzawa locations
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