数据经理
Data Manager
职位名称：数据管理员
工作地点：德国弗赖堡（远程）
此职位向德国弗赖堡办公室（Heinrich-von-Stephan-Straße 5 | 79100 Freiburg Germany）汇报，为完全远程工作，无需出差。
我们是谁：
TriNetX 连接全球的医疗保健机构和研究人员，让他们能够看到真实患者群体中发生的情况——而不是猜测或模拟。我们的目标简单而雄心勃勃：提供一条通往可信答案的清晰路径，无论您的目标是开发有前景的新疗法、发表突破性的研究，还是改善健康结果。我们将可识别的数据保留在其所在的位置——在20多个国家的11000多个临床站点中，确保安全、来源和粒度。我们与医疗机构的可信合作确保了高质量的数据，并能正确地将数据追溯到个体患者。在 TriNetX，我们使生命科学、医疗保健和学术机构能够加强人类健康——通过可追溯的数据、可辩护的证据和可信赖的答案。
我们寻找的人：
数据管理员负责所有观察性、流行病学（EPI）和真实世界肿瘤学研究中的电子病例报告表（eCRF）的技术开发、编程、验证、质量保证、维护和多阶段锁定。
您将负责：
· EDC 设置、数据库启用及 eCRF 架构
◦ 创建数据库模式并向 EDC 供应商提交正式启用请求。 ◦ 为患者级研究（TherapyMonitor、External Control Arms）和中心级汇总调查（ATU、EPI 和可行性研究）编程和配置结构化的 eCRF。 ◦ 配置中央查找表、字段前提条件和标准化数据库列名，以实现无缝的统计导出。 ◦ 模块化表单结构（例如，划分重复的治疗周期），以防止临床站点录入时出现性能延迟。 ◦ 协调项目翻译并在 secuTrial® 中配置欢迎屏幕和站点说明。
· 质量保证、验证与数据管理计划
◦ 在 secuTrial® 中编程自动字段验证、范围限制、一致性规则以及描述性错误/警告查询信息。 ◦ 使用标准化 Excel VBA 宏生成和维护项目特定的数据管理计划；将手动监查检查和离线查询与项目管理和数据分析对齐。 ◦ 在 secuTrial® 中配置自动不良事件（AE）和非适应症使用（OLU）通知。
查看英文原文
POSITION TITLE: Data Manager
LOCATION: Freiburg, Germany (Remote)
This position reports to our Freiburg, Germany office (Heinrich-von-Stephan-Straße 5 | 79100 Freiburg Germany) and is fully remote with no expected travel.
Who We Are:
TriNetX connects healthcare organizations and researchers across the globe so they can see what’s happening in real patient populations—not guesses, not simulations. Our aim is simple and ambitious: Provide a clear path to trustworthy answers, whether your goal is to create promising new therapies, publish groundbreaking research, or improve health outcomes. We keep identifiable data where it belongs—inside more than 11,000+ clinical sites across 20+ countries—preserving security, provenance, and granularity. Our trusted partnerships with providers ensure high-fidelity data, and a properly governed linkage back to individual patients. At TriNetX, we enable life sciences, healthcare, and academic institutions to strengthen human health—with data you can trace, evidence you can defend, and answers you can trust.
Who We Are Looking For:
The Data Manager is responsible for the technical development, programming, validation, quality assurance, maintenance, and multi-stage locking of electronic Case Report Forms (eCRFs) across all observational, epidemiological (EPI), and real-world oncology studies.
What You Will Be Doing:
· EDC Setup, Database Commissioning & eCRF Architecture
◦ Creation of Database Schemas and submit official commissioning requests to EDC vendor. ◦ Program and configure structured eCRFs for patient-level studies (TherapyMonitor, External Control Arms) and center-level aggregated surveys (ATU, EPI and Feasibilities). ◦ Configure centralized lookup tables, field preconditions, and standardized database column names for seamless statistical export. ◦ Modularize form structures (e.g., dividing repetitive therapy cycles) to prevent performance lag during clinical site entry. ◦ Coordinate project translations and configure welcome screens and site instructions in secuTrial®.
· Quality Assurance, Validation & Data Management Plans
◦ Program automated field validation, range limits, consistency rules, and descriptive error/warning query messages in secuTrial®. ◦ Generate and maintain the project-specific Data Management Plan using standardized Excel VBA macros; align manual Monitoring Checks and offline queries with Project Management and Data Analysis. ◦ Configure automated Adverse Event (AE) and Off-Label Use (OLU) notification alerts. ◦ Perform mandatory test data entry runs covering all visit branches, logic rules, and validation triggers prior to production deployment.
· Production Releases, Productive Changes & Lifecycle Control
◦ Authorize and verify overnight automated production releases, backing up project setups and generating annotated eCRFs. ◦ Configure all necessary settings and permissions in the productive environment. ◦ Implement mid-study eCRF modifications without data loss; document all structure/variable changes. ◦ Adapt established survey structures for subsequent waves or new project cycles.
· User Administration, Multi-Stage Database Locking & Archiving
◦ Provision and manage center profiles, user roles, and granular data access rights in AdminTool / CustomerAdminTool; deactivate departed personnel. ◦ Execute Stage 1 (freeze new patient creation), Stage 2 (freeze form entry except open queries), and Stage 3 (final database lock and Super-User closure) upon field completion. ◦ Archive project databases from servers and secure all study documentation in designated SharePoint folders.
· Training, Interdisciplinary Collaboration & QMS Maintenance
◦ Conduct and log EDC onboarding and role-specific technical training for new project managers, data analysts, and clinical monitors. ◦ Act as primary technical liaison between PM (feasibility/protocol), DA (variable naming/export tables), and Clinical Monitoring (query workflows). ◦ Author, review, and update DMO SOPs/WIs during annual review cycles.
What You Bring to TriNetX:
- A minimum of a bachelor's degree in medical information management or similar field.
- Ideally, professional training as a medical documentarist, medical information manager or a comparable qualification.
- Experience in handling electronic data capture (EDC) systems.
- HTML/JAVA/SQL knowledge is an advantage.
- A strong interest in oncology, particularly in familiarizing yourself with the treatment guidelines for specific indications.
- The capacity to work flexibly in a goal-oriented manner, and a strong spirit of collaboration within a team setting.
- Business fluent German and English.
Preferred:
- Master's degree in medical information management.
- Ability to quickly learn new topics and interest in developing skills in healthcare data environments (e.g., GxP).
- Additional language skills beyond German and English are an advantage.
Learn more about TriNetX:
To learn more about us, please check out our website, blog, and Careers page - and be sure to follow us on LinkedIn.
Interested in joining our community?
TriNetX is an Equal Opportunity Employer. All persons are considered for employment without regard to their race, color, creed, religion, national origin, ancestry, citizenship status, age, disability or handicap, sex or gender, marital status, sexual orientation, genetic information, gender identity, veteran status, or any other characteristic or status protected by applicable federal, state or local laws.
This Organization Participates in E-Verify
This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment. Employers can only use E-Verify once you have accepted a job offer and completed the Form I-9.
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For more information on E-Verify, or if you believe that your employer has violated its E-Verify responsibilities, please contact DHS.
888-897-7781
Originally posted on Himalayas