SSU 资深专员(J15112)

AI 摘要智能生成

独立负责多家中心（含高难度中心）的启动全流程

职位描述

你将负责 / What you will do · 独立负责多家中心（含高难度中心）的启动全流程 Independently run end-to-end start-up for 10–20 sites across 2–3 studies, including complex sites · 主导中心合同与预算谈判，按 FMV 原则与公司费用标准落地条款 Lead contract and budget negotiations in line with FMV and company fee standards · 处置伦理反复退审、机构流程不清、研究者意愿变化等复杂卡点 Resolve complex blockers: repeated ethics deferrals, unclear institutionalworkflows, shifting interest · 审核知情同意书与中心特定模板的本地合规性，推动版本定稿 Review the local compliance of informed consent forms and site-specific templates · 复核专员产出的递交资料与关键文件，守住第二道质量关 Review packages and documents prepared by Specialists as the second quality gate · 带教 1–2 名专员，沉淀中心画像与常见退审意见清单 Coach 1–2 Specialists and build reusable assets such as an ethics-comment library

任职要求

• 我们期待你 / What we are looking for
• 本科及以上，医药相关专业，硕士优先
• Bachelor degree or above in a pharmaceutical or life-science discipline; master's preferred
• 3–5 年 SSU 或等效经验，独立负责过 10 家以上中心启动
• 3–5 years of SSU experience with independent ownership of 10+ site activations
• 具备AI相关经验优先
• AI relevant experience are preferred.
• 熟悉 NMPA 法规、人遗办要求、伦理与机构规则，了解合同与 FMV 合规要求
• Familiar with NMPA regulations, HGRAC requirements and contract / FMV compliance
• 谈判与影响力强，能在信息不全时作出判断并承担结果
• Strong negotiator; decides with incomplete information and owns the outcome
• 英文可作为工作语言
• English usable as a working language