We are looking for an Data Manager in clinical trials to join our team at Eurofins bioskin. The Data Manager is responsible for creating Case Report Forms (eCRF/pCRF), developing and maintaining study databases, and coordinating data entry, data cleaning, and query management.
Your main responsibilities:
- Familiarization with current scientific developments within the scope of the task area
- Participation in/organization of meetings and telephone conferences in-house / with clients / training sessions, seminars
- Development and implementation of strategies for the introduction of clinical research databases in accordance with the applicable international standards (ICH, GCP, CDISC) and
- Development of (e)CRF standard modules and
- Creation and revision of data management SOPs and the workflows described therein
- Project management within the scope of DM activities
- Preparation of a study-specific schedule/schedule (timelines) of tasks related to the function in coordination with the relevant departments
- Creation and adherence to the audit-specific Data Management Plan and related documents
- Definition, programming and validation of completeness and plausibility checks (edit checks) and data transfer.
- Data review, data cleaning and query Management
- Third Party data / Device data handling
- Coding of diseases, adverse events and drugs according to study-specific coding systems, e.g. WHO Drug Global or MedDRA.
- Organization and execution of third party and SAE reconciliation.