强生
Sr Local Trial Manager
Sr Local Trial Manager
发布于 2 小时前普通员工/个人贡献者
全职员工仅现场办公临床研究
临床研究
Ctms系统
Gcp合规
临床试验管理
生物医学
站点监测
英语沟通
跨部门协作
项目管理
预算控制
值不值得投
80综合评分
综合评分 80
跨国药企核心研发管理岗，使命驱动强、平台资源优，出差频率较高但晋升通道清晰。
从薪资福利、成长发展、工作生活和使命价值四个维度综合评估，方便横向比较。
薪资怎么样
2.4万
比临床研究中位数高
发布情况
新岗位 · 今天发布
公司情况
这家公司招聘很活跃
约 250 个在招 · 其中临床研究 4 个
市场机会
选择面较广
北京 · 临床研究 · 约 170 个在招
职位详情
关于这个职位
负责在中国地区独立管理临床试验项目，从启动到数据库锁定及关闭的全流程运营监督
作为国家层面主要联系人，协调本地试验团队确保数据质量与合规性，并指导初级临床助理与监查员
需具备药物研发流程知识，熟悉GCP及当地法规，能够进行预算预测、风险管理及跨部门沟通
最低要求
A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
Minimum two to four years of pharmaceutical and/or clinical trial experience is preferred (including site monitoring experience), however other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including GCP and local regulatory requirements. Willingness to travel with occasional overnight stay away from home.
Solid leadership skills. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills
工作职责
Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and CTM/GTL. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list.
Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs
Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
Maintains and updates trial management systems. Uses study tools and management reports available to analyse trial progress
Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
May submit requests for vendor services and may support vendor selection.
In certain situations, may assist in negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.
Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting
Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed
Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.
Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements
Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits
Complies with relevant training requirements.
Acts as subject matter expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent GCO on cross functional teams.
Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.
Actively contributes to process improvement, training and mentoring of CTAs, SM and other LTMs.
Conducts accompanied site visits with SM as delegated by FM.
May assumes additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.
May represents functional area in process initiatives as required
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
优先资格
Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred. The ability to lead initiative/small teams.
Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel.
AI 洞察
优缺点分析
优点
- 依托全球顶尖医药平台，接触前沿疗法与高标准研发流程
- 系统化培训与导师制，利于积累完整的临床试验管理经验
- 清晰的职级晋升通道与完善的薪酬福利体系
- 国际化工作环境，显著提升跨文化沟通与项目管理能力
- 频繁出差拜访研究中心与医院，对体力与时间管理要求高
- 适合具备医药背景、追求规范化职业发展、抗压能力强且热爱临床试验项目管理的人才
缺点 / 挑战
- 临床试验周期长、节点多，需同时跟进多个项目，工作压力较大
- 合规与监管要求严格，任何流程偏差都可能引发严重风险
角色解读
- 纵向可晋升为高级临床项目经理(CTM)或区域临床运营负责人
- 横向可拓展至医学事务、注册申报或药物安全监测领域
- 长期可向临床试验总监或研发运营管理高管方向发展
- 负责单一国家/地区临床试验的全流程本地化管理，从站点启动到数据库锁定及关闭
- 作为本地主要联系人，协调临床助理、监查员及跨部门团队，确保试验按计划推进
- 监控试验进度与数据质量，处理不良事件报告，管理预算与供应商
- 指导初级团队成员，优化本地试验流程，确保符合GCP及当地法规
- 扎实的临床试验项目管理能力，熟悉药物研发全流程及GCP法规
- 出色的跨部门沟通与利益相关方管理能力，能高效对接内外合作方
- 熟练使用CTMS等试验管理系统，具备数据分析与风险管控意识
- 优秀的中英文书面及口头表达能力，适应高频出差与多项目并行
申请策略
- 提前了解目标企业当前重点治疗领域（如肿瘤、免疫、罕见病）的研发管线
- 面试中着重展现对合规红线与风险管理的敬畏心及实操经验
- 突出主导或参与的具体临床试验项目规模、治疗领域及个人角色
- 量化展示站点招募进度、预算控制率及合规零缺陷成果
- 强调中英双语沟通能力及跨部门协调解决复杂问题的案例
- 深入学习ICH-GCP最新指南及中国NMPA临床试验法规
- 掌握主流CTMS系统操作及临床试验数据统计分析基础
- 提升PMP或敏捷项目管理方法论在实际场景中的应用
面试指南
- 采用STAR法则（情境-任务-行动-结果）结构化回答，突出关键决策点
- 强调以数据驱动和SOP为依据的合规管理思路，而非单纯追求速度
- 展现主动沟通、风险前置预判及跨团队协同解决问题的闭环思维
- 请分享一个你成功管理过的复杂临床试验项目，你是如何确保按期交付的？
- 当研究中心进度严重滞后或出现重大方案违背时，你会如何处理？
- 如何平衡临床试验的质量合规要求与项目进度/成本控制？
- 请举例说明你如何指导或培训初级临床团队成员提升工作效率
- 熟读目标治疗领域的常见临床试验方案设计与GCP核心条款
职位点评
薪资福利85
成长发展80
工作生活65
使命价值90
薪资福利
85较高
岗位属于资深专业序列，结合一线城市市场水平与2-4年经验要求，整体薪酬竞争力较强，配套福利体系较为完善。
薪资信号偏高 (1.8千–3.0万/月)
成长发展
80较高
岗位明确提及导师制、流程改进参与及跨职能团队机会，技术栈聚焦主流现代临床试验管理，成长路径清晰。
技术前沿主流现代技术
技术栈GCP、CTMS、临床试验管理、药物研发流程
成长机会training and mentoring、process improvement、cross functional teams
业务类型ambiguous
工作生活
65中等
岗位允许一定程度的弹性与远程协作，但明确要求频繁出差及夜间住宿，整体生活化动机满足度中等。
工作模式未明确
办公地点科技园/产业园
加班情况未提及（无法判断）
使命价值
90较高
岗位所属研发运营方向直接关联人类健康改善与社会福祉，行业前景稳定且社会价值显著，高度契合意义感动机。
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prevent, treated, and cured、impact health for humanity
创新程度积极采用新技术
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