Clinical Study Admininstrator (m/f)

Job type:
Start date:
24 MM
Hays AG
near Bern
Published at:
flag_no Switzerland
Contact person:
Kerstin Sieber
Project ID:

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

Reference: en
Start: asap
Duration: 24 MM
Place: near Bern
Branch: Tabakverarbeitung

Your tasks:
  • Support o the Clinical Study Team (organization of meetings, coordination of document reviews)
  • Set-up of paper and electronic Study Master File (SMF)
  • Ensure that SMF agreements are executed with CROs and followed throughout the study
  • Ensure SMFs transfers and check completeness of the SMFs upon receipt
  • 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
  • Support preparation, revision and editing of SOPs
  • Track all invoices related to clinical contracts
  • Stay up to date with ICH GCP knowledge
  • Supervision of one administrative staff

Your qualifications
  • Profound experience in the field of clinical study administration 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

- Clinical trial associate
- Clinical trial assistant