Your tasks

• You are responsible for Clinical Data Management for clinical studies from conception to database closure, ensuring high data quality and on-time milestones.
• You will develop and review data management plans, data validation plans, edit-check specifications, and other study-specific documentation.
• You will lead the selection, management, and professional collaboration with CROs and other service providers in the field of Clinical Data Management.
• You are responsible for the conception, development and quality assurance of eCRF, IRT, eCOA and ePRO systems, including the implementation of questionnaires, licensing issues and validation.
• You control the programming, execution and documentation of user acceptance tests, as well as the release of databases and system changes.
• You plan and coordinate ongoing data reviews, data cleansing, query management, external data matching, and the tracking of data quality risks.
• You ensure the reconciliation of the clinical database with safety and laboratory databases.
• You prepare data review meetings, present data quality metrics, and derive appropriate measures together with the relevant departments.
• You are responsible for preparing and executing database locks, including freeze, lock and archiving activities, as well as the necessary documentation.
• You will further develop processes, work instructions and standards in Clinical Data Management and provide support during audits, inspections and in answering data management-related questions.
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