Clinical Trial Administrator Consultant

8 mesi fa


Bologna, Italia Alira Health A tempo pieno

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

The Clinical Trial Administrator Consultant will manage and review the study documents of clinical trials

**Job Description**:
Study documentation and Trial Master File (TMF):

- Responsible for reviewing the paper TMF (all Zones of DIA Ref.Model) of some closed studies, including the check of the completeness of the TMF, the quality of the documentation and the correctness of the TMF location. ,
- Responsible for TMF and paper TMF reconciliation after study completion
- Be involved in TMF inspections
- Manage NDA Filing
- Collaborates with the CPM with corrective and preventive actions, in case of deviations and audits.

Languages

Education

Contract Type

Contingency Workforce



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