Data Manager

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.

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.