Clinical Sciences Trial Leader Job at Universal Hierarchy Node, 東京都

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  • Universal Hierarchy Node
  • 東京都

Job Description

Summary

在适当的监督下,为全球临床试验活动的所有相关方面做出贡献,以在时间表,预算,质量/合规性和绩效标准内提供研究成果。可能主导全球临床试验的特定方面。临床试验团队的核心成员,通过流程改进和知识共享和/或为临床开发流程提供投入,为卓越运营做出贡献。

~适用于临床科学专家II
临床科学专家II(CSE II)在(A)CD(M)D的指导下,根据诺华流程,ICH GCP和法规要求,在临床研究的所有阶段提供临床和科学支持。该角色应用临床数据审查卓越原则,并确定临床数据见解,以确保数据在科学上是合理的,并确定与试验终点和患者安全相关的趋势,信号和风险。 CSE II是临床试验团队(CTT)的核心成员。此外,CSE II支持/领导分配的计划级别文档或活动。

About the Role

Major Accountabilities

~ 根据时间表、预算、运营程序、质量/合规性和性能标准,为特定 JD 范围内的所有操作/临床试验交付成果做出贡献。
~ 开展/协助研究启动活动,如监督协议制定、通用报告格式开发、知情同意表单开发。
~ 确保正确处理所有学习行为和关闭活动,包括但不限于现场关闭、最终药物问责和审判主文件文件的审计准备情况(如果属于特定JD的范围)。
~ 负责在指定的临床试验和临床计划内进行临床操作/临床数据审查活动的教育、实施和遵守标准 (SOP) 和最佳实践,包括分享经验教训。
~ 在收到诺华产品后24小时内报告与诺华产品相关的技术投诉/不良事件/特殊情况
~ 营销样本的分发(如适用)

Key Performance Indicators

在适当的监督下,为全球临床试验活动的所有相关方面做出贡献,以在时间表,预算,质量/合规性和绩效标准内提供研究成果。可能主导全球临床试验的特定方面。临床试验团队的核心成员,通过流程改进和知识共享和/或为临床开发流程提供投入,为卓越运营做出贡献。

~适用于临床科学专家II
临床科学专家II(CSE II)在(A)CD(M)D的指导下,根据诺华流程,ICH GCP和法规要求,在临床研究的所有阶段提供临床和科学支持。该角色应用临床数据审查卓越原则,并确定临床数据见解,以确保数据在科学上是合理的,并确定与试验终点和患者安全相关的趋势,信号和风险。 CSE II是临床试验团队(CTT)的核心成员。此外,CSE II支持/领导分配的计划级别文档或活动。

Work Experience

~运营管理和执行
~项目管理
~财务管理
~跨界协作
~临床研究阶段
~临床试验设计、数据审查和报告
~跨界协作

Skills

~数据完整性
~趋势分析
~临床试验
~临床试验方案
~生命科学
~临床研究
~风险监控
~学习设计
~数据分析
~辅导
~预算管理

Language

英语

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