- Education medical information management or equivalent qualification, or Clinical Research Associate training
- 3 years of relevant pharmaceutical industry experience and GCP-training is beneficial.
How you ll spend your day - Performs Central Monitoring for clinical study/trial of the eTMF/ CTMS documents in study database TGEC to ensure GxP compliance of study conduct by contract research organizations/vendors in accordance with SOPs and checklists.
- Supports maintenance and quality control procedures of essential documents of eTMF/ CTMS documents in study database TGEC for clinical study/trial according to ICH-GCP and other study-related documents according to TMF plans/EDLs and SOPs/BPGs
- Supports knowledge collection on TMF maintenance/study documents collection and documentation
- Key contact for study managers on central monitoring questions
- Supports to Manager Clinical Research and CSOM/CSM
- Reports to Manager Clinical Research
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