Data Manager
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Job Description
Data Manager configuring and validating clinical eCRFs for TriNetX, which connects healthcare organizations and researchers with real-world patient data. Managing database locks, EDC systems, and study documentation.
Responsibilities:
- Create database schemas and submit commissioning requests to the EDC vendor
- Program and configure structured eCRFs for patient-level studies and center-level aggregated surveys
- Configure lookup tables, field preconditions, standardized database column names, and modular form structures
- Coordinate translations and configure welcome screens and site instructions in secuTrial
- Program automated field validation, range limits, consistency rules, and query messages
- Generate and maintain project-specific Data Management Plans using Excel VBA macros
- Configure automated Adverse Event and Off-Label Use notification alerts
- Perform mandatory test data entry before production deployment
- Authorize and verify automated production releases, back up project setups, and generate annotated eCRFs
- Configure productive-environment settings and permissions
- Implement mid-study eCRF modifications without data loss and document changes
- Adapt survey structures for subsequent waves or project cycles
- Manage center profiles, user roles, and granular data access rights
- Execute staged database freezes, final database locks, and Super-User closure
- Archive project databases and secure study documentation in SharePoint
- Conduct and log EDC onboarding and technical training
- Liaise between Project Management, Data Analysis, and Clinical Monitoring
- Author, review, and update DMO SOPs and WIs
Requirements:
- Minimum of a bachelor's degree in medical information management or similar field
- Ideally, professional training as a medical documentarist, medical information manager or comparable qualification
- Experience handling electronic data capture (EDC) systems
- HTML, Java, and SQL knowledge is an advantage
- Strong interest in oncology and willingness to learn treatment guidelines for specific indications
- Ability to work flexibly in a goal-oriented manner
- Strong team collaboration
- Business-fluent German and English
- Master's degree in medical information management preferred
- Ability to quickly learn new topics and interest in healthcare data environments such as GxP preferred
- Additional language skills beyond German and English are advantageous
Benefits:
- Equal Opportunity Employer
- E-Verify participation
- Fully remote work with no expected travel
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