临床研究运营经理
Operations Manager, Clinical Research
Milestone One 是一家站点支持服务公司，总部位于瑞士苏黎世。我们了解临床研究站点的需求，我们的总体使命是支持站点更高效地开展研究。
运营经理负责根据 Milestone One 的合同义务，监督指定国家或地区内合作医疗机构的临床试验的日常运作。运营经理为首席站点协调员和站点协调员提供领导和支持，是操作问题的专家和上报点。该职位在人员发展、流程改进和持续运营卓越方面起着关键作用。
职责范围
· 通过审查临床、操作和资源需求，评估研究方案的可行性，并推荐适合医疗机构的试验。
- 监控预算谈判和研究启动时间表，以支持站点及时准备。
- 管理（首席）研究协调员团队，通过监控和跟进研究相关报告、工时表、站点跟踪器和其他操作工具，监督其工作质量和成果，确保 Milestone One 团队的满意表现。
- 推动流程改进和临床试验操作的标准化，符合 ICH GCP、监管要求和 MO1 控制文件，通过参与制定操作指南、模板和程序来做出贡献。
- 创建一个促进流程透明度、责任性和持续学习的工作文化环境。
- 生命科学或相关专业的学士学位。具有商业管理学位或证书者优先。
- ICH GCP 培训认证
- 至少 5 年临床现场工作经验，有领导岗位经验，在临床研究机构或网络中工作的经验非常受欢迎。
- 熟悉从预授权到结题的临床研究活动全过程。
- 英语流利
- 熟练使用 MS Office
- 有效的 B 类驾照
- 优秀的沟通能力
- 优秀的管理能力，有远程员工管理经验者优先。
- 有效的解决问题能力和结果导向
- 具有责任感
- 团队领导能力
如果你希望加入一家以人为本、注重个人价值的快速发展公司，你独立且有责任感，Milestone One 就是你的选择。
查看英文原文
Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.
The Manager Operations is responsible for overseeing the operational conduct of clinical trials at
contracted medical institutions within a defined country or region in accordance with Milestone One
contractual obligations. The Manager Operations provides leadership to Lead Site Coordinators and
Site Coordinators, serving as a subject matter expert and escalation point for operational issues. This
position plays a key role in staff development, process improvement, and continuous operational
excellence.
SCOPE OF RESPONSIBILITIES
· Assesses feasibility of research protocols by reviewing clinical, operational, and resource requirements and recommending suitable trials for the medical institution.
- Monitors the progress of budget negotiations and study activation timelines to support timely site readiness.
- Manages the team of (Lead) Study Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and other operational tools to ensure satisfactory performance of the Milestone One team.
- Drives process improvement and standardization of clinical trial operations in alignment with ICH GCP, regulatory requirements, MO1 Controlled Documents, by contributing to the development of operational guidelines, templates, and procedures.
- Creates a work culture environment that promotes process transparency, accountability, and continuous learning.
- Associate degree in life sciences or similiar. Business Management degree or certification is a plus.
- Certifications ICH GCP Training
- Minimum 5 years of clinical on the job experience, in a leadership position at a clinical research facility or Network experience is highly preferred.
- Knowledgeable and direct experience in the full life cycle of clinical research activities from pre-award through close out.
- Fluent use of English
- Proficiency in MS Office
- Valid category B driver’s license
- Excellent communications skills
- Excellent management skills, experience managing remote staff preferred.
- Effective problem solving and result oriented
- Accountable
- Team leadership skills
If you want to join a developing company where people matter, you're independent and accountable, Milestone One is the right place for you.