Global Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based
职位标题:全球试验经理,晚期研究,单人赞助商专业 (家庭工作地点:雷丁,伯克希尔,英国的工作地点类型:远程工作合同类型:全日制工作资深级别:高级全球试验管理员单人赞主 你在全球层面管理晚期临床试验方面有经验吗?我们正在寻找一名高级全球试点经理加入我们的单人赞成部门。加入我们的全球团队并承担提供符合时间表,预算和质量标准的晚期临终试验的所有权。作为核心临床试验团队 (CTT)的成员,你将领导全球研究的关键方面,并跨职能合作推动成功。作为你的角色的一部分,你有机会专业化在以下领域之一:·科学审查委员会 (SRC) ·非干预性研究 (NIS) ·管理访问计划 (MAP) ·研究者启动试验 (IITs) ·研究协作 (RCs) ·项目级文件 (PLD) 主要责任:临床文档和学习工具 ·协议草案部分,CRFs,培训材料和数据评估计划 ·为安全更新,IBs 和监管提交项目的领导力做出贡献 ·监督数据审查和 TMF 审计准备性 ·预测/管理调查产品供应 ·支持研究结局,解决问题和生命周期预算跟踪 · 促进管理访问计划协调与合规的供应商和利益相关者管理 ·协调 CRO/供应商选择和绩效 · 便利咨询委员会 (DMCs/委)并担任现场联络人员 · 领导与数据管理,药物供应等多项跨职能合作 · 你将带来什么?• 生物科学或医疗保健高级学位 · 25年的全球经验管理第四阶段,PASS,PAES 或 NIS 试验 · 协议开发,研究启动和监管性写作 (例如 PSUR,DSUR,NDA/BLA 报告)· 优秀的沟通,组织和协作技能 · 深入了解 GCP 和临床试验设计 · 对实践证据和患者结果的热情请注意:由于该角色的赞助人要求,仅将考虑名单所在地。这些地点以外的候选人的任何申请都不会被考虑.IQVIA 是全球领先的机构。
查看英文原文
Job Title: Global Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based
Job Location: Reading, Berkshire, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Senior Global Trial Manager – Single Sponsor
Are you experienced in managing late phase clinical trials at a global level?
We are looking for a Senior Global Trial Manager to join our Single Sponsor Department.
Join our global team and take ownership of delivering late-phase clinical trials that meet timelines, budgets, and quality standards. As a core Clinical Trial Team (CTT) member, you'll lead critical aspects of global studies and collaborate across functions to drive success.
As part of your role, you’ll have the opportunity to specialise in one for the following areas:
·Scientific Review Committee (SRC)
·Non-Interventional Studies (NIS)
·Managed Access Programs (MAP)
·Investigator-Initiated Trials (IITs)
·Research Collaborations (RCs)
·Program Level Documents (PLD)
Key Responsibilities:
Clinical Documentation & Study Tools
- Draft sections of protocols, CRFs, training materials, and data review plans
- Contribute to the development of safety updates, IBs, and regulatory submissions
Project Leadership
- Oversee data review and TMF audit readiness
- Forecast/manage investigational product supply
- Support study closeout, issue resolution, and lifecycle budget tracking
- Contribute to Managed Access Program coordination and compliance
Vendor & Stakeholder Management
- Coordinate CRO/vendor selection and performance
- Facilitate advisory boards (DMCs/Steering Committees) and serve as the site liaison
- Lead cross-functional collaboration with data management, drug supply, and more
What You'll Bring
- Advanced degree in life sciences or healthcare
- 2–5 years' global experience managing phase IV, PASS, PAES, or NIS trials
- Strong track record in protocol development, study startup, and regulatory writing (e.g. PSURs, DSURs, NDA/BLA reports)
- Excellent communication, organizational, and collaboration skills
- Deep understanding of GCP and clinical trial design
- Passion for advancing real-world evidence and patient outcomes
Please note this role is not eligible for the UK visa sponsorship.
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at .
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Originally posted on Himalayas