精鼎医药
Study Start Up Specialist II
Study Start Up Specialist II
发布于 大约 3 小时前普通员工/个人贡献者
广州市
中级经验
全职员工
仅现场办公
本科
医疗、制药与临床研究
MS Office
ICH-GCP
SSU
Regulatory Affairs
Contract Negotiation
AI 估算 · 10k–18k
跨国CRO的SSU岗位，要求英语和临床研究经验，市场稀缺度较高，薪资具有竞争力。
职位详情
关于这个职位
该职位是临床试验启动专员（SSU），负责协调临床试验启动阶段的各项活动，包括伦理委员会申请、合同谈判、法规提交等
需要与医院、伦理委员会及内部团队紧密合作，确保研究中心按时启动
适合有1.5年以上SSU经验、熟悉中国临床试验法规和ICH-GCP的专业人士
最低要求
>1.5 years of proved SSU experience in clinical trials, experience in global company is preferred.
Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in China.
Achieved a satisfactory level of technical, functional, and/or professional skill/knowledge in position – related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.
University Degree or equivalent preferably in a medical/science-related field.
工作职责
SSU Coordination and Execution:
Coordinates, guides, and assists with all start up activities prior to site activation, including but not limited to: Site Informed Consent Form (ICF) localization and guidance; Ethics Committee information, meeting dates & costs; Ethics applications & associated online systems; Ethics & Governance submission processes; Clinical Trial Health Authority application and regulatory submission process; Contracts & Indemnity request process; For global studies, localize global ICF with country requirements; Local sample application and permit submission processes.
Maintains up to date knowledge, ensuring adherence and compliance with local regulatory requirements and associated documentation.
Reviews, analyzes, and collates metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation.
Ensures all start up information & requirements are kept up to date in a central repository for both global and local study teams.
Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department.
Tracks metrics and SSU timelines to identify trends and opportunities for improvement.
Relationship management:
Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial processes, government policies/laws, via innovative approaches.
Maintains current, and awareness of changes in, startup processes across government, hospital & industry & liaises with stakeholders to resolve any SSU issues.
Proactively responds to information survey requests by government/industry bodies.
Provides continuous and proactive communication with ECs/hospital administration/industry bodies.
Maintains communication with local legal/regulatory/clinical operation to ensure input is sought and all internal/external requirements are met.
Provides guidance to Country Study Managers (CSMs) and Country Study Specialist (CSS) on regulatory/ethics.
Collaborates with vendor management and procurement.
Liaises and shares best practices with other SSU within the region/organization.
New Site Identification:
Assists with identification and tracking of new sites in collaboration with CSMs.
Performs/coordinates site level feasibility activities.
Contracts/Budget:
Negotiates contracts and study budgets with sites during the SSU phase.
Provides local fee structures and budgetary advice; ensures compliance to Fair Market Value (FMV).
Collaborates with CSMs to maintain data to ensure FMV.
Liaises with management/CSMs to implement budget cost containment and contingencies.
Compliance with Parexel standards:
Complies with required training curriculum. Completes timesheets accurately. Submits expense reports. Updates CV as required. Maintains working knowledge of Parexel processes, ICH-GCP and other applicable requirements.
AI 洞察
优缺点分析
优点
- 加入全球领先CRO，接触国际多中心研究，积累行业经验
- 岗位专业性强，能深入掌握中国临床试验启动的核心流程和法规
- 公司平台大，培训体系完善，有利于长期职业发展
- 工作内容涉及大量文档和流程协调，对细节和耐心要求高
- 与多方沟通（医院、伦理、内部），需要较强的抗压和协调能力
- 适合细心、沟通能力强、有临床研究背景的求职者，特别是希望深耕临床试验启动领域的人
缺点 / 挑战
- 需要同时管理多个中心，时间压力较大，可能出现加班
角色解读
- 可向SSU经理或临床运营经理发展，负责更大区域或项目
- 也可转向临床研究项目经理（CRA/PM）或法规事务岗位
- 在大型CRO积累经验后，有望进入制药公司担任临床运营角色
- 负责临床试验启动阶段的全流程协调，包括伦理委员会申请、合同谈判、法规提交等
- 与医院、伦理委员会、内部团队及监管部门沟通，确保研究中心按时启动
- 跟踪项目进度，管理SSU相关文档和指标，推动效率提升
- 熟悉ICH-GCP和中国临床试验法规，具备SSU实战经验
- 优秀的英语沟通能力（书面和口语），能够与全球团队协作
- 良好的项目管理和组织能力，能同时处理多项任务
- 熟练使用MS Office和数据库系统，注重细节
申请策略
- 了解Parexel公司文化和主营业务，面试时展示对CRO行业的热情
- 准备一两个成功推进SSU项目的案例，展示问题解决能力
- 突出SSU相关经验，包括具体参与过的研究类型、中心数量、关键成果
- 强调项目管理能力和英语水平，用实例说明如何推动启动进程
- 列出熟悉的法规知识（ICH-GCP、中国GCP）和工具（CTMS、eTMF等）
- 可以提前学习ICH-GCP最新指南和中国临床试验相关法规
- 提升英语能力，尤其是商务英语写作和口语表达
- 如果缺乏SSU经验，可通过CRA或临床协调员岗位过渡
面试指南
- 使用STAR法则（情境、任务、行动、结果）结构化回答行为问题
- 对于流程问题，展示逻辑性：先分析问题，再提出解决方案，最后总结教训
- 体现团队协作和沟通能力，强调与各方协调的具体做法
- 请描述一次你成功推动研究中心启动的经历
- 如何处理伦理委员会审批延迟的情况？
- 如何同时管理多个中心的启动任务？
- 你如何确保合同和预算符合公平市场价值？
- 请谈谈你对中国临床试验法规变化的理解
职位点评
65
综合评分
跨国CRO的SSU岗位，专业性强，发展稳定，薪资未明确。
更适合这类人
该职位最适合注重专业成长和职业稳定性的求职者，尤其是希望在临床试验领域深耕的人员。
表现最好
成长发展
相对薄弱
薪资福利
薪资福利60
成长发展70
工作生活60
使命价值70
薪资福利
60中等
薪资未在JD中明确，但作为跨国CRO的专业岗位，预计薪资中等偏上，福利可能包括五险一金、补充医疗等，但JD未提及，满足程度一般。
薪资信号未披露（AI估算：10K-18K/月）
成长发展
70中等
岗位能积累临床试验启动的深度经验，接触全球项目，有明确的专业发展路径，但JD未明确提及晋升或培训，故评分中等偏高。
技术前沿非技术岗（不适用）
业务类型ambiguous
工作生活
60中等
仅现场办公，未提及远程或弹性工作，工作强度可能较大，但地点在广州，城市生活便利。
工作模式仅现场办公
办公地点未明确
加班情况未提及（无法判断）
使命价值
70中等
参与临床试验启动有助于新药上市，对患者有益，具有一定社会价值；行业稳定发展，但JD未突出使命感。
行业发展稳定成熟行业
社会影响中性/一般
创新程度稳健跟随主流
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