Data Manager (fmd)

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.

Qualifications :

• University degree in natural sciences or other comparable degree
• Working knowledge of ICH GCP guidelines
• Experience in development of data structures according to CDISC standards would be a nice to have
• Dependable well-structured and organized target-oriented personality team player
• 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.

Remote Work :

Yes

Employment Type :

Full-time