Job Description
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:
1. Familiarization with current scientific developments within the scope of the task area
2. Participation in/organization of meetings and telephone conferences in-house / with clients / training sessions, seminars
3. Development and implementation of strategies for the introduction of clinical research databases in accordance with the applicable international standards (ICH, GCP, CDISC) and
4. Development of (e)CRF standard modules and
5. Creation and revision of data management SOPs and the workflows described therein
6. Project management within the scope of DM activities
7. Preparation of a study-specific schedule/schedule (timelines) of tasks related to the function in coordination with the relevant departments
8. Creation and adherence to the audit-specific Data Management Plan and related documents
9. Definition, programming and validation of completeness and plausibility checks (edit checks) and data transfer.
10. Data review, data cleaning and query Management
11. Third Party data / Device data handling
12. Coding of diseases, adverse events and drugs according to study-specific coding systems, e.g. WHO Drug Global or MedDRA.
13. Organization and execution of third party and SAE reconciliation.
Qualifications
14. University degree in natural sciences or other comparable degree
15. Working knowledge of ICH GCP guidelines
16. Experience in development of data structures according to CDISC standards would be a nice to have
17. Dependable, well-structured and organized, target-oriented personality, team player
18. Well versed in English (written and spoken)
Additional Information
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your application including anticipated salary.