Study Administrator (m/f)

Description

• 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