全球研究负责人 - FSP
Global Study Lead - FSP
工作时间
标准（周一至周五）
工作环境
办公室
职位描述
职位描述
全球研究负责人 – 该职位是一个完全客户嵌入式角色，专注于一家领先的生物制药公司。
职位目的：
该全球研究负责人（GSL）是唯一负责的人员，并作为临床运营代表。将推动运营策略、计划和研究的领导工作，并与资产策略保持一致。GSL 和 GSM 作为领导-运营搭档共同工作。
主要职责：
1. 全球研究领导
- 负责全球临床研究的日常管理
- 领导跨职能研究团队（临床运营、数据管理、统计学、医学监测、监管、供应链、安全等）
- 确保全球战略与区域执行的一致性
- 推动研究时间表、里程碑和交付成果
2. 研究计划与执行
- 制定并维护：
- 研究时间表
- 运营计划
- 风险管理计划
- 入组策略
- 监督国家启动、站点激活、招募、监查和结题
- 确保协议在全球范围内一致执行
3. 供应商和CRO监督
- 管理外部供应商和CRO合作伙伴
- 跟踪绩效指标和服务质量
- 解决运营问题和升级情况
- 确保供应商履行合同义务和时间表
4. 预算和资源管理
- 监控研究预算和预测
- 跟踪研究支出与计划的对比
- 识别资源缺口和运营风险
- 支持财务治理和变更管理
5. 风险与问题管理
- 早期识别研究风险
- 领导缓解和应急计划
- 处理以下相关升级：
- 入组延迟
- 协议偏离
- 数据质量问题
- 供应短缺
- 检查准备
6. 法规与质量合规
- 确保研究实施符合：
- ICH-GCP
- 当地法规
- 标准操作规程（SOPs）
- 协议要求
- 支持检查准备和审计活动
- 在需要时监督纠正和预防措施（CAPAs）
7. 跨职能沟通
- 作为研究的中央运营联系人
- 向以下对象汇报更新：
- 高级管理层
- 研究团队
- 区域团队
- 客户/合作伙伴
- 主持治理会议和研究评审
8. 数据与研究监督
- 监控入组、数据清理、问题解决和数据库锁定准备情况
- 审核关键绩效指标（KPIs）和运营指标
- 确保及时交付高质量数据
9. 战略决策
查看英文原文
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Job Description
Global Study Lead – This position is a fully client-embedded role, dedicated to a leading bio-pharma company.
Role Purpose:
This GSL is a single accountable person and a Clinical Operations representative. Will drive operational strategy, planning and leading the study and being aligned with the asset strategy. The GSL and GSM work s a leadership-operational duo.
Key Responsibilities:
1. Overall Study Leadership
- Own the day-to-day management of the global clinical study
- Lead cross-functional study teams (clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, safety, etc.)
- Ensure alignment between global strategy and regional execution
- Drive study timelines, milestones, and deliverables
2. Study Planning and Execution
- Develop and maintain:
- study timelines
- operational plans
- risk management plans
- enrollment strategies
- Oversee country start-up, site activation, recruitment, monitoring, and closeout
- Ensure protocol execution is consistent globally
3. Vendor and CRO Oversight
- Manage external vendors and CRO partners
- Track performance metrics and service quality
- Resolve operational issues and escalations
- Ensure vendors meet contractual obligations and timelines
4. Budget and Resource Management
- Monitor study budgets and forecasts
- Track study spend against plan
- Identify resource gaps and operational risks
- Support financial governance and change management
5. Risk and Issue Management
- Identify study risks early
- Lead mitigation and contingency planning
- Handle escalations related to:
- recruitment delays
- protocol deviations
- data quality issues
- supply shortages
- inspection readiness
6. Regulatory and Quality Compliance
- Ensure study conduct follows:
- ICH-GCP
- local regulations
- SOPs
- protocol requirements
- Support inspection readiness and audit activities
- Oversee CAPAs when needed
7. Cross-Functional Communication
- Serve as the central operational contact for the study
- Communicate updates to:
- senior leadership
- study teams
- regional teams
- sponsors/partners
- Lead governance meetings and study reviews
8. Data and Study Oversight
- Monitor enrollment, data cleaning, query resolution, and database lock readiness
- Review KPIs and operational metrics
- Ensure timely delivery of quality data
9. Strategic Decision-Making
- Make operational decisions that impact study delivery
- Balance quality, speed, cost, and patient safety
- Recommend process improvements and efficiencies
Education Requirements:
- Bachelor’s degree: life sciences or related discipline; The role will require a good understanding of complex clinical development and regulatory processes.
Role Related Experience:
- At least 6+ years of relevant study management experience on a global level.
- In-depth experience in clinical research: study management, monitoring, data management
- Previous in-depth Oncology experience
- Must have exposed to clinical study management “end-to-end” Globally : NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset –
- Must have proven experience from study feasibility to CSR
- Must have at least Ph II and PIII experience – PI & PIV is an asset
- Must have cross-functional leadership proven experience, able to drive internal and external meeting
- Able to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systems
- Strong experience in clinical budget management
- Strong experience with vendor management including CRO
- Exposed to competent authority Inspections (FDA, EMA, MHRA, PMDA...), being involved in studies pivotal for drug file registration is an asset
- Fluent in English, to the level they can negotiate and discuss (adapt message) related to complex topics with any Clinical team member (Local country representative, Statistician, Data Manager, laboratory, central laboratory, Scientific writer, safety representative, study Phycician and any type of vendors as well as able to present clear status to upper management if required.
- Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.
- Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
- Strong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
- Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)
Originally posted on Himalayas