Clinical Data Manager (m/f)

- Responsible for performing clinical data management activities on various outcome surveys
- Perform data management activities related to an EDC study
- Participate in the design and development of Outcome Surveys to ensure compliance with GCP/ICH, company SOPs and best working practices
- Assist in the development, review and maintenance of data management plans and other required documentation necessary for the study
- Review documents, such as CRF, DB specifications, edit check specifications for the database/data management system and objects for manual review
- Organize and participate in User Acceptance Testing (UAT) for EDC studies
- Review clinical data for accuracy and consistency of data and generate and follow issues through the query management process until resolution
- Review coding listings from CRO to ensure accuracy and consistency of coded data, and raise corresponding queries
- Perform Serious Adverse Event Reconciliation
- Ensure all required documentation is completed and appropriately archived

- Thoroughly understand GCP (Good Clinical Practice) for clinical data management activities
- Have experience working with data management contract research organizations (CROs) and/or EDC application vendors
- Experience in SAE reconciliation
- Be familiar with the MedDRA coding process
- Have ability to identify potential areas for additional data cleaning activities
- Have solid understanding of database design and downstream effects

Weitere Qualifikationen: Clinical data manager