SSU 资深专员(J15112)

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

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