赛纽仕
Site Activation Specialist I/II - Beijing
Site Activation Specialist I/II - Beijing
发布于 2 天前普通员工/个人贡献者
北京市
中级经验
全职员工
仅现场办公
本科
TMF
ICH GCP
Regulatory Affairs
Clinical Trial Start-Up
Essential Document Management
Site Contracts
AI 估算 · 15k–25k
北京CRO临床启动岗，中级经验，跨国大平台，薪资有竞争力，月薪约15k-25k。
职位详情
关于这个职位
该职位负责中国区临床试验中心的启动工作，包括文件准备、递交伦理和监管机构、合同谈判等
作为跨国CRO公司的核心运营岗位，需要协调多方推动项目按时启动
适合有临床试验背景、擅长流程管理和沟通的求职者
最低要求
Bachelor’s Degree
Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
Ability to understand clinical protocols and associated study specifications
Detailed understanding of clinical trial start-up processes
Ability to manage external vendors to contract effectively
Strong organizational skills with ability to handle multiple tasks effectively
Strong written and verbal communication and interpersonal skills
Ability to manage multiple project budgets with increased complexity and value
Quality-driven in all managed activities
Good negotiating skills
Good problem-solving skills
Demonstrated ability to work independently as well as part of a team
工作职责
Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager. Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified.
Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Responsible for the Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SAM. May serve as a point of contact for the PM/SAM (or designee) during start-up on allocated projects. Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager.
May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/ site level.
Country Start-Up Advisor - Acts as Subject Matter Advisor for in-country performance within the Site Start-Up. Supports country-level intelligence on start-up (SU) and clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/export license applications where these are obtained with RA applications. In absence of legal advisor or dedicated subject matter may provide support for data protection at the country and provide guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This may include the Principal Investigator/Informed Consent and the Confidential Disclosure Agreement/contract template. Provides input in local SOPs and WI. Supports the creation of internal training materials on local legislation requirements. Provides input to the team to assist with EC or CA issue resolution at the country level. Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
May be asked to perform: Local Investigator Contract and Budget Negotiator – Provides support to SAM to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site. Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SAM with Sponsor until resolution of issues and contract execution. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
AI 洞察
优缺点分析
优点
- 全球领先的CRO平台，积累丰富的临床试验启动经验，接触创新药物和跨国项目
- 公司提供清晰的职业发展路径和培训资源，有助于个人快速成长
- 职位涉及跨部门协作和合同谈判，能锻炼综合项目管理能力
- 北京作为临床研究重镇，行业机会多，岗位稳定性高
- 需要与多方沟通（研究中心、监管机构、内部团队），协调成本高，可能出现推诿或延迟
- 法规和SOP更新频繁，需持续学习，保持合规意识
- 适合有1-3年临床试验或CRO经验、注重流程规范、善于沟通和解决问题的求职者
缺点 / 挑战
- 工作节奏较快，需在多项目间切换，时间管理压力较大
角色解读
- 纵向发展：从Site Activation Specialist晋升为SSU Country Manager或Regional Start-Up Lead，管理更大范围团队
- 横向拓展：转向临床运营（Clinical Operations）、项目管理（Project Management）或监管事务（Regulatory Affairs）等方向
- 行业深耕：积累经验后可进入申办方（药企）从事临床开发或项目管理岗位，或向战略采购、供应商管理方向发展
- 负责中国地区临床试验中心的启动全流程管理，包括递交伦理委员会、监管机构及医院审批
- 收集、审核和提交研究中心的必备文件，确保符合ICH GCP和公司SOP要求
- 与研究中心、申办方及内部团队协调，推动项目按时达成启动里程碑
- 参与研究中心合同谈判和预算协商，跟踪财务执行情况
- 深入理解II-IV期临床试验流程及ICH GCP规范，能够独立解读临床方案
- 出色的组织和多任务处理能力，能同时管理多个研究中心的启动工作
- 优秀的书面和口头沟通能力，能有效与内部团队、研究中心及监管机构沟通
- 良好的谈判和问题解决能力，能处理合同、预算及突发问题
申请策略
- 在求职信中表达对临床试验行业和患者价值的认同，强调对细节和质量的追求
- 提前了解Syneos Health的公司文化（如Driven to Deliver），在面试中展现契合度
- 突出临床试验启动或项目管理经验，量化交付的里程碑和节省的时间
- 强调对ICH GCP和当地法规的理解，列出参与过的监管递交类别
- 展示合同谈判或预算管理的具体案例，体现谈判成果和财务敏感性
- 用STAR法则描述解决复杂问题的经历，如处理延迟启动或文件问题
- 熟悉中国临床试验法规（如NMPA相关指南）和ICH GCP最新更新
- 学习使用临床试验管理系统（CTMS）或电子TMF系统，提升数字化工具能力
面试指南
- 使用STAR法则：情境、任务、行动、结果
- 强调流程化管理：如利用追踪系统、定期跟进、提前预警
- 体现沟通策略：主动倾听、明确期望、寻求双赢解决方案
- 请描述一次你成功推动临床试验中心启动的经历，遇到哪些挑战？如何解决的？
- 你对ICH GCP和中国的临床试验法规了解多少？请举例说明如何确保合规
- 如何管理多个研究中心的启动时间线？使用过哪些工具或方法？
- 请分享一次与研究中心或监管机构谈判合同或预算的例子
- 如果研究中心递交文件不全，你会如何处理？
匹配度报告
69
综合匹配度
跨国CRO临床启动岗位，发展空间大，社会意义强，但现场办公且工作节奏快。
适合人群
适合看重职业成长、培训机会和社会价值的求职者，对工作生活平衡要求不高。
最强匹配
成长发展匹配
最弱匹配
工作生活匹配
薪资福利70
成长发展85
工作生活40
使命价值80
薪资福利匹配
70中等
薪资估算为市场中等偏上，但JD未提及具体福利，大公司稳定性较好，但薪酬信号一般。
薪资信号未披露（AI估算：15K-25K/月）
成长发展匹配
85较高
JD明确提到职业发展、内部培训、导师支持，且公司平台大，成长路径清晰。
技术前沿传统/成熟技术
技术栈ICH GCP、SOP、TMF
成长机会career development and progression、technical and therapeutic area training、supportive and engaged line management
业务类型ambiguous
工作生活匹配
40较低
JD未提及远程或弹性工作，推测为现场办公，且临床试验启动工作强度可能较高，WLB信号弱。
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）
使命价值匹配
80较高
公司强调改善患者生活，加速药物开发，社会意义较强，但具体职位影响相对间接。
行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号accelerate customer success、shape the future of healthcare、driving impact for customers and defining the pace of patient progress
创新程度稳健跟随主流
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