Trial Data Manager; m​/f​/d

Aufgaben

• Regulatory & Internal Compliance:
  Guarantees that all clinical data management and biometry tasks for the designated study comply with internal innovation standards and applicable regulatory requirements
• Milestone Delivery:
  Achieves all study timelines and milestones regarding data management outputs and deliverables
• Data Consistency:
  Maintains uniform data handling, processing, and validation methods across all allocated clinical trials
• Project Leadership:
  Directs, leads, and oversees end-to-end data management workflows for the specified study
• Protocol Input:
  Contributes critical data management expertise and insights during the drafting and design phase of the study protocol
• eCRF Setup:
  Coordinates and manages the creation, design, and setup of the electronic Case Report Form (eCRF) according to company standards
• Technical Documentation:
  Authors comprehensive data management documentation, including specifications for external data transfers, data cleaning, and validation tools to guide DM Programmers during development
• Trial Archiving:
  Compiles, organizes, and properly archives all required trial data management files and documentation
• UAT & Deployment:
  Coordinates and tracks the User Acceptance Testing (UAT) of data entry screens, cleaning tools, and their final deployment into the live production environment
• Database Lock Management:
  Supervises data cleaning, data review, query resolution, and the final database lock procedure, ensuring close collaboration with Clinical Development stakeholders
• Reporting & Analytics:
  Produces regular study metrics, analytics, and progress reports for management review
• CTT Representation:
  Serves as the primary Data Management representative and subject matter expert during Clinical Trial Team (CTT) sessions
• Stakeholder Presentations:
  Prepares and delivers presentations on data-related topics at CTT, investigator, and monitor meetings
• Vendor & CRO Management:
  Takes full accountability for outsourced studies, effectively managing relationships, timelines, and deliverables with external partners
• SOP Development:
  Assists in authoring, updating, and reviewing standard operating procedures (SOPs), policies, and related data management guidance documents
• Cross-Functional Working Groups:
  Acts as the DM liaison in cross-functional task forces focused on system, tool, and process optimizations
• Resource Forecasting:
  Anticipates, projects, and forecasts staffing and resource needs for the assigned study team
• Team Training:
  Verifies that all data managers working on the trial have completed the necessary training and onboarding
• Annotated CRF:
  Coordinates the timely generation, validation, and delivery of the annotated CRF (aCRF)
• Quality Control (QC):
  Executes and coordinates routine Quality Control checks to ensure data handling aligns precisely with the protocol, Quality System guidelines, and GCP
• Operational Flexibility:
  On-site presence at the innovation hub is expected. Steps in to perform standard Data Manager tasks if no junior DM is allocated to the study

• Educational Background:
  Master’s degree (M.Sc.) in Life Sciences, Statistics, Mathematics, Informatics, or a closely related scientific discipline
• Industry
  
  Experience:
  
  Minimum of 5 years of professional experience within the pharmaceutical or biotech sector, specifically in Clinical Research or Clinical Data Management, showcasing a strong level of functional expertise
• Communication
  
  Skills:
  
  Exceptional organizational capabilities alongside excellent English communication skills (both written and spoken)
• Regulatory Knowledge:
  Thorough understanding of global clinical trial regulations and requirements, particularly ICH-GCP guidelines
• Technical Proficiency:
  Solid background in clinical databases, data architecture/flow, data validation procedures, and electronic CRF design
• Team Coordination:
  Proven capability to mentor, guide, and coordinate the activities of other Data Managers working on the same study
• Presentation Power:
  Strong proficiency in task management and professional presentation delivery to diverse stakeholders