赛纽仕
Sr Site Activation Manager (CHN/TWN/HK/SGP/MYS)
Sr Site Activation Manager (CHN/TWN/HK/SGP/MYS)
发布于 大约 14 小时前中层管理(经理/总监)
北京市
高级经验
全职员工
仅现场办公
本科
医疗、制药与临床研究
ICH GCP
SSU
Problem-Solving
Regulatory Affairs
Negotiation
AI 估算 · 25k–40k
Sr Manager级别，CRO行业，北京，经验要求高，薪资有竞争力，年终奖约1个月。
职位详情
关于这个职位
作为资深站点启动经理，您将负责领导和管理临床试验的站点启动流程，涵盖从站点选择到启动就绪的全生命周期
您需要协调跨部门团队，确保项目按时按质交付，同时维护客户关系并优化预算
该职位适合拥有丰富CRO或临床试验经验、精通SSU流程和ICH GCP的专业人士
最低要求
Bachelor’s Degree, Higher Degree Preferred.
Minimum 6 years CRO industry experience and/or a minimum 5 years’ experience working in a SSU, or clinical trial environment or an equivalent combination of education and experience.
Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
Good understanding clinical protocols and associated study specifications.
Excellent understanding of clinical trial start-up processes.
Project management experience in a fast-paced environment.
Good vendor management skills.
Strong organizational skills with proven ability to handle multiple projects.
Excellent communication, presentation and interpersonal skills.
Quality-driven in all managed activities.
Strong negotiating skills.
Strong problem-solving skills.
Demonstrate an ability to provide quality feedback and guidance to peers.
工作职责
Collaborates with major functional areas including Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing.
Identifies and evaluates fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented.
Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk identification, mitigation and management.
Develops and maintains relationships with customers in alignment with their assigned projects.
Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.
Provides oversight of all project start-up deliverables which encompasses all activities from site selection through site activation ready and into the life cycle maintenance of projects.
Assumes accountability on start-up deliverables including Site Identification and selection, Start-up and life cycle maintenance regulatory activities, Oversight of delivery of executed clinical trial agreements and investigator budgets, Establishing and overseeing Essential Document collection leading to site activation, Overall SSU timelines.
Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes.
Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.
Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team.
Reviews the project SSU budget with functional leads, PM, and SSU Business Unit Controller against project milestones and budget to ensure project profitability.
Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures effective budget management.
Prepares the core submission documents and core clinical trial application dossier for amendments during life cycle maintenance.
Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation.
Responsible for or assists in initial or amendment updated development of master Subject Information Sheet/Informed Consent Form.
Oversees collation, quality review, and submission of country-specific applications.
Contributes to change initiatives across and within the SSU department.
Ensures all relevant documents are submitted to the Trial Master File.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
AI 洞察
优缺点分析
优点
- 全球领先的CRO公司，平台大，项目资源丰富，能接触多种治疗领域
- 职位级别高，有管理职责和客户互动机会，有利于职业发展
- 公司注重员工发展，提供培训、导师制和职业晋升通道
- 工作强度较大，需要同时管理多个项目并应对紧迫的启动时间线
- 可能需要出差（最多25%），对工作生活平衡有一定影响
- 适合具有丰富CRO或临床试验SSU经验、善于多任务处理、沟通能力强且希望向管理层发展的资深专业人士
缺点 / 挑战
- 薪资和福利有竞争力，且为上市公司，稳定性较高
- 行业法规严格，需保持高度准确性和合规意识，压力较大
角色解读
- 可晋升为Associate Director或Director of Site Activation，管理更大团队和区域
- 也可转向项目管理或临床运营管理方向，成为临床运营负责人
- 积累丰富的SSU经验后，可成为CRO行业的高级顾问或专家
- 领导和管理临床试验的站点启动全流程，包括站点选择、伦理审批、合同签署、文件收集等
- 与跨部门团队（商务、项目管理、临床、数据管理等）协作，确保项目按时按质交付
- 维护客户关系，定期汇报项目进展，识别风险并制定缓解措施
- 管理项目预算，确保盈利，并处理合同变更和范围外工作
- 精通临床试验II-IV期流程及ICH GCP规范，熟悉SSU流程
- 出色的项目管理能力，能同时管理多个项目并在快节奏环境中工作
- 优秀的沟通、谈判和人际交往能力，能与客户和团队高效协作
- 强大的问题解决和决策能力，能够处理复杂问题并推动解决方案
申请策略
- 申请时强调对患者中心和加速疗法交付的热情，与公司使命契合
- 了解Syneos Health近期项目或客户案例，在面试中展示对公司的了解
- 突出SSU或临床试验项目管理的具体经验，包括成功启动的站点数量和类型
- 强调跨部门协作和客户管理的成果，如客户满意度、项目按时交付率
- 展示谈判和预算管理能力，例如合同谈判案例或成本控制成果
- 列出熟悉的相关法规（ICH GCP、当地法规）和工具（TMF、CTMS）
- 如果尚未取得PMP认证，可考虑考取以增强项目管理资质
- 加强临床方案解读和数据分析能力，特别是对复杂问题的决策能力
面试指南
- 使用STAR法则（Situation-Task-Action-Result）回答问题，突出您的角色、具体行动和量化结果
- 对于管理类问题，展示您的领导力和决策过程
- 请描述一次您成功加速站点启动的案例，您是如何克服挑战的？
- 您如何同时管理多个项目的SSU时间线，并确保每个项目按时交付？
- 当客户要求缩短启动时间但资源有限时，您如何处理？
- 您如何评估和选择研究站点？请分享您的标准和方法
- 请举例说明您如何与监管机构或伦理委员会沟通以解决审批问题
- 准备2-3个详细的SSU项目管理案例，包括难点、策略和成果
匹配度报告
71
综合匹配度
全球CRO巨头Sr Manager，薪资高、成长好，但WLB一般，需出差。
适合人群
该职位最适合追求职业成长、薪资竞争力强、能接受一定工作压力的资深专业人士。
最强匹配
成长发展匹配
最弱匹配
工作生活匹配
薪资福利80
成长发展85
工作生活50
使命价值70
薪资福利匹配
80较高
该职位为Sr Manager级别，薪资在CRO行业处于较高水平，且公司为上市巨头，福利待遇有保障，能较好满足补偿性动机。
薪资信号偏高 (25K-40K/月)
成长发展匹配
85较高
公司明确提到职业发展、技术培训、导师制，且职位本身管理职责强，成长空间大，发展性动机满足程度高。
技术前沿传统/成熟技术
技术栈ICH GCP、SSU、Regulatory
成长机会career development and progression、technical and therapeutic area training
业务类型profit_center
工作生活匹配
50较低
职位要求可能出差（最多25%），未提及弹性办公或远程，工作强度较大，生活化动机满足一般。
工作模式仅现场办公
办公地点市区核心地段
加班情况未提及（无法判断）
使命价值匹配
70中等
CRO行业与药物研发相关，具有一定社会价值，但职位更偏向商业运营，使命驱动感中等。
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 the delivery of therapies、change lives
创新程度稳健跟随主流
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