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.

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.