Clinical Study Administrator (m/f)

Job type:
Start date:
12 MM+
Hays AG
near Bern
Published at:
flag_no Switzerland
Contact person:
Kerstin Werner
Project ID:

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We are looking for a
Clinical Study Administrator (m/f)

Reference: en
Start: asap
Duration: 12 MM+
Place: near Bern
Branch: Tabakverarbeitung

Your tasks:
  • 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

Your qualifications
  • 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

- Clinical trial assistant

Keywords: Clinical Trial Assistant