临床试验数据经理
Data Manager for Clinical Trials
PSI 是一家领先的合同研究组织（CRO），在制药行业拥有 30 年的经验。PSI 起源于瑞士，是一家私有全服务 CRO，业务遍及全球，支持多个国家和大洲的临床试验。我们对所承担项目的高度选择性体现了我们对在多种治疗适应症领域提供高质量、及时服务的承诺。
在 PSI，我们营造一个让各类同事感到欢迎和被重视的环境。我们的包容文化是成功的关键，使我们能够吸引并留住全球顶尖人才。
我们不仅仅是在进行临床试验；我们是在建立一个社区，让每位团队成员都有机会成长，并为制药行业的突破性进展做出贡献。
临床数据经理在临床研究项目中扮演关键角色。如果你注重细节，致力于质量，能够处理大量临床或医学数据，你可能是我们正在寻找的专业人士。
请提交你的英文简历
职责包括：
· 跟踪数据库的建立、测试、维护和数据录入
· 与客户、项目团队和供应商沟通数据管理相关事宜
· 审核研究文件，设计并开发项目特定的指南和说明
· 设计电子病例报告表（eCRF）、数据管理及数据验证计划，并测试电子数据采集（EDC）数据库
· 确保数据录入、跟进和验证，包括手动 CRF 审核和严重不良事件（SAE）核对
· 编码医学数据
· 跟踪并报告导致数据库锁定的指标
· 协调 CRF/问题单的处理、发送和归档
· 维护临床数据管理的工作文件
· 执行数据库质量检查，准备并参与审计
· 对现场人员和项目团队进行 CRF 填写和数据管理主题的培训
- 大学/学院学位（生命科学、药学专业优先）
- 具备管理临床或医学数据的经验
- 英语流利
- 有临床数据管理系统经验（如 Medidata Rave、Oracle InForm）
- 熟练使用 MS Office 应用程序
- 优秀的组织和时间管理能力
- 能够独立工作并处理多任务
如果你觉得是时候在一个真正关注员工发展的成长型公司中展示你的技能和知识，那么 PSI 就是你的正确选择。
查看英文原文
PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.
At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.
We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.
Clincial Data Manager plays a critical role in the clinical research project. If you are detail-oriented and committed to quality, able to work with large volume of clinical or medical data, you might be the professional we are looking for.
Please submit your CV in English
Responsibilities will include:
· Track database set-up, testing, maintenance and data entry
· Communicate with clients, project teams and vendors on data management matters
· Review study documents, design and develop project specific guidelines and instructions
· Design eCRF, Data Management and Data Validation Plans and test EDC databases
· Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
· Code medical data
· Track and report metrics leading to database lock
· Coordinate the processing, dispatch and archiving of CRFs/queries
· Maintain Clinical Data Management working files
· Perform database QC checks, prepare and attend audits
· Train site staff and project teams on CRF completion and data management topics
- College/University degree (Life Science, Pharmacy degree is a plus)
- Demonstrated experience of managing clinical or medical data
- Full working proficiency in English
- Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm)
- Proficiency in MS Office applications
- Organisational and time management skills
- Ability to work independently and multi-task
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.