Study Administrator (m/f)

-Organization and participation to Clinical Study Team meetings, including distribution of agenda and meeting notes
-Set-up of paper and electronic Study Master File
-Ensures that CROs/sites use agreed SMF structure and naming convention for electronic files
-Organization / coordination with CROs / sites of transfer of SMFs to PMI
-Check completeness of the SMFs upon receipt form external partners and ensures that any missing documents are obtained
-Archive documents electronically in DMS and ensure that documents in DMS are consistent with paper SMF
-Archiving of paper SMFs
-Assures QC checks of selected study documents
-Provide support to the preparation and maintenance of the GCP training program for the clinical team
-Track all invoices related to clinical contracts
-Stay up to date with ICH GCP knowledge
-Proven experience in the field of clinical study conduct required (CRO, Pharmaceutical, Biotech, Medical Device industry)
-Previous experience in Quality Assurance / Quality Control is an advantage
-Knowledge of Documentum or other Document Management System (DMS) is an advantage
-Fluent English (oral and written)
-Strong interpersonal skills and strong team player
-Good knowledge of MS Office Suite, capacity to learn the use of other IT tools
-Knowledge of other languages (e.g. Japanese) is an advantage

Weitere Qualifikationen: Clinical trial assistant,