Clinical Study Administrator (m/f)

Description

• Support the Clinical Study Team (organisation of meetings, coordination of document reviews)
• Set-up and maintenance of paper and electronic Study Master File (SMF)
• Ensure SMF transfers from CROs to PMI and check for completeness of the SMFs upon receipt
• Perform reconciliation and QC checks of the SMFs upon receipt and ensure that any missing documents are obtained
• Archive documents electronically in e-TMF and ensure that documents in e-TMF are consistent with paper SMF
• Perform archiving of paper SMFs
• Provide support and act as back-up for the e-TMF clinical study administrator
• Support preparation, revision and editing of SOPs, perform QC of these documents
• Assures QC checks of selected study documents
• Support Clinical Assessment team in the preparation of any audits and inspections; coordinates collection of documents, meetings etc.
• Stay up to date with ICH GCP knowledge

• Experience in the field of clinical study administration required (CRO, Pharmaceutical, Biotech, Medical Device industry)
• Experience in Quality Assurance/Quality Control is of advantage
• Knowledge of Documentum or other Document Management System (DMS) is of advantage
• Fluency in English (oral and written)
• Strong interpersonal skills and strong team player mentality
• Good knowledge of MS Office Suite, capacity to learn the use of other IT tools
• Knowledge of other languages (e.g. Japanese) is of advantage