Tmf Specialist

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

To manage and review the study documents of clinical trials

**Job Description**:
Main Responsibilities
- Study documentation and Trial Master File (TMF/eTMF)
- Responsible for eTMF/paper TMF (in particular sections 10 and 11 of DIA Ref.Model) management of assigned studies, including the check of the completeness of the TMF, the quality of the documentation and the correctness of the TMF location.
- Responsible for eTMF and paper TMF reconciliation after study completion
- Be involved in TMF inspections.
- Collaborates with the project team with corrective and preventive actions, in case of deviations and audits.

**Requirements**:
Proven experience in TMF Management;

Knowledge of Statistical and Data Management Processes

English fluency

Languages

Education

Contract Type

Contingency Workforce