Data Curation Manager

• Initiate, coordinate, supervise and support contractual activities related to image data cooperations with external partners (e.g. annotation service providers, imaging providers and/or contract research organizations, R&D, Product Owners and Product Management).
• Establish data gathering and data curation processes and pipelines aimed to support medical software device development and ensure processes are in compliance with medical device regulations (e.g. GDPR, ML/AI related regulations).
• Coordinate data transfer from external partners to BL internal database ready to use for development and validation purposes.
• Collect product derived data requirements from stakeholders inside and outside of own department and implement into the data gathering and data curation process.
• Identify and supervise external annotation experts (e.g. medical consultants or data curators)
• Support R&D as internal annotator & quality reviewer, providing clinical input for validation, for software development, usability and risk management activities
• Support the design of project outlines and other study related documents aimed for image gathering & gold standard annotations.
• Ensure data cooperations are in compliance with the latest applicable regulations and guidelines (e.g., ISO, FDA, MDR) and provide feedback to Legal and QM
• Attend conferences and meetings of scientific and medical committees and boards and report back to the marketing team new developments and trends
• Author & review clinical evaluation related documentation like Data Curation Report, Annotation Guidelines, Clinical Evaluation Plan, Clinical Evaluation Report, Post Market Surveillance Plan, Periodic Safety Update Report, Summary of Safety and Clinical Performance
• Perform clinical and technical State of the Art literature searches, device related literature searches including appraisal and analysis
• Manage and perform post market surveillance and all depending activities for PMCF or involve/assign other experts (like product managers, clinical evaluator)

The position potentially qualifies for full-time remote home office work with regular monthly on-site team meetings.