Your tasks

• Responsibility for the development, maintenance and continuous optimization of electronic Trial Master File (eTMF) systems
• Ensuring complete , up-to-date and inspection-ready study documentation in accordance with ICH-GCP and regulatory requirements.
• Management and quality assurance of study-related documents throughout the entire study lifecycle
• Supporting Clinical Operations Teams in structuring, filing, and tracking study documents
• Maintenance and administration of CTMS and eTMF systems
• Conducting quality controls and regular TMF reviews
• Identification and implementation of process improvements in document management
• Collaboration with internal departments, CROs, sponsors and testing centers
• Support during audits and inspections, as well as preparation of corresponding documentation .
• Creation and updating of standard operating procedures (SOPs) and process documentation

Your profile

• Completed studies in the field of life sciences, healthcare or a comparable qualification
• First to several years of professional experience in Clinical Operations, Clinical Trial Management, TMF Management or Study Coordination
• Practical experience with eTMF and/or CTMS systems
• Good knowledge of ICH-GCP guidelines and relevant regulatory requirements
• Structured, meticulous and quality - oriented work methods
• Analytical thinking and an interest in process optimization
• Confident use of MS Office and electronic document management systems
• Excellent German and English skills, both spoken and written.
• 
  
•