Ihre
**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
Ihr Profil
- 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
