远程工作雷达

试验委员会经理

Trial Committee Manager

其他未标注地域
公司PSI CRO
薪资未公开
工作地点Amsterdam, NH, Netherlands
地域资格未标注地域
时区要求无特别要求
用工类型Full-time
发布时间2026-08-11
数据来源SmartRecruiters
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PSI 是一家全球合同研究组织(CRO),拥有超过 30 年支持全球临床研究的经验。我们结合了成熟组织的稳定性与推动现代临床试验所需的敏捷性和创新性。我们致力于质量与按时交付,与多个治疗领域的客户合作,同时为员工提供一个可以成长、贡献并对全球医疗健康产生有意义影响的环境。

试验委员会经理负责临床试验委员会(IDMC、安全审查委员会、裁定委员会等)的全流程管理,这些委员会在整个临床试验生命周期中提供无偏见的监督和专家指导。在这一职位上,您将作为发起方、委员会成员和跨职能 PSI 团队的协调中心,确保委员会活动高效、合规且达到最高质量标准。您将与全球项目团队和外部专家合作,支持多种治疗领域临床试验的成功交付。

您将负责:
· 管理临床试验委员会的全生命周期,从委员会建立和成员选择到试验实施和结题。
· 协调临床试验全过程中的委员会会议、沟通、建议和后续活动。
· 制定、维护和更新委员会章程、程序和其他试验相关文件。
· 根据试验需求、专业知识、可用性和独立性标准,识别、评估并聘请合格的外部委员会成员。
· 进行公平市场价格评估,并为独立委员会成员准备酬金估算。
· 支持与委员会管理活动相关的审计和检查,并在需要时参与纠正和预防措施。
· 参与委员会相关质量文档、业务流程、模板和培训材料的开发和持续改进。
· 支持内部关于委员会管理流程的培训计划和实施。

  • 生命科学、药学、医疗保健、临床研究或相关领域的学士学位。
  • 至少 3 年的临床研究经验,最好是在 CRO 环境中。
  • 有管理或协调临床试验的经验
查看英文原文

PSI is a global Contract Research Organization (CRO) with over 30 years of experience supporting clinical research around the world. We combine the stability of an established organization with the agility and innovation needed to advance modern clinical trials. Guided by a commitment to quality and on-time delivery, we partner with clients across a broad range of therapeutic areas while providing our employees with an environment where they can grow, contribute, and make a meaningful impact on global healthcare.

The Trial Committee Manager oversees the end-to-end management of clinical trial committees (IDMC, Safety Review Committee, Adjudication Committee etc.) that provide unbiased oversight and expert guidance throughout the lifecycle of clinical trials. In this role, you will serve as the central point of coordination for sponsors, committee members, and cross-functional PSI teams, ensuring committee activities are executed efficiently, compliantly, and to the highest quality standards. You will collaborate with global project teams and external experts to support the successful delivery of clinical trials across a variety of therapeutic areas.
You will be responsible for:
· Managing the full lifecycle of clinical trial committees, from committee setup and member selection through study conduct and close-out.
· Coordinating committee meetings, communications, recommendations, and follow-up activities throughout the course of clinical trials.
· Developing, maintaining, and updating committee charters, procedures, and other trial-specific documentation.
· Identifying, evaluating, and engaging qualified external committee members based on study requirements, expertise, availability, and independence criteria.
· Performing Fair Market Value assessments and preparing honorarium estimates for independent committee members.
· Supporting audits and inspections related to committee management activities and contributing to corrective and preventive actions, as needed.
· Contributing to the development and continuous improvement of committee-related quality documentation, business processes, templates, and training materials.
· Supporting the planning and delivery of internal training on committee management processes.

  • Bachelor's degree in Life Sciences, Pharmacy, Healthcare, Clinical Research, or a related field.
  • At least 3 years of experience in clinical research, preferably within a CRO environment.
  • Experience managing or coordinating clinical trial committees or comparable experience in clinical trial management with exposure to committee processes.
  • Proven project management and stakeholder coordination skills, with the ability to manage multiple priorities in a fast-paced environment.
  • Strong organizational, communication, and problem-solving skills with exceptional attention to detail.
  • Ability to build effective working relationships with sponsors, external experts, and cross-functional teams.
  • Professional proficiency in English (written and spoken).
  • Proficiency in Microsoft Office applications and virtual meeting platforms.

Join a collaborative, globally connected team dedicated to ensuring the highest standards of independent clinical trial oversight. In this role, you'll work closely with sponsors, renowned external experts, and cross-functional teams to facilitate unbiased committee governance that supports critical decisions throughout the clinical trial lifecycle.
If you're passionate about clinical research, thrive in a highly organized, stakeholder-facing environment, and enjoy coordinating complex projects that make a real impact on the quality of clinical trials, we'd love to hear from you.

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