Your area of ​​responsibility

• Study databases: Design and validation of study databases and CRFs in EDC systems (e.g., REDCap)
• Data verification: Planning and support of data review, data cleaning and query management
• Reporting: Establishing automated reports to monitor study status
• Data export: Preparing data exports for internal and external analysis
• Digitalization: Support for the digitalization of clinical trial processes and tools
• eDocumentation: Collaboration in the introduction of electronic documentation, signatures and eTMF processes.
• Data concepts: Development of concepts for pseudonymization and data provision
• System landscape: Participation in the development and networking of study IT systems (e.g. FIS, CTMS)
• Regulatory aspects: Ensuring regulatory compliance of data management (GCP, data protection)
• Documentation: Creation and maintenance of SOPs, data management plans and quality documents
• Audits: Preparation for audits and inspections, as well as support in training study staff.

Your profile

• Qualifications: Completed university degree (Master's/Diploma) in medical documentation, health sciences, mathematics, computer science or a comparable field, or completed vocational training in the healthcare sector (e.g., medical documentarian) with relevant additional qualifications.
• Industry experience: Ideally, experience in a medical or healthcare environment, confident use of medical terminology, and knowledge of GCP and data protection are advantageous.
• IT skills: Proficient in MS Office and experience with EDC systems (e.g., REDCap, SecuTrial) and SQL
• Language skills: Very good German skills (min. C1) and good English skills
• Soft skills: High reliability, loyalty and commitment, structured and independent work style, excellent communication skills and strong organizational talent