Clinical Trial Associate (long-term)

Your tasks

  • Project coordination and document review to support the Clinical Study team
  • Set-up and maintenance of Study Master Files (SMF)
  • Ensure SMFs transfers from CROs to company and check for completeness nad quality of the SMFs upon receipt
  • Archive documents electronically in e-TMF and ensure that documents in e-TMF are consistent with paper SMF
  • 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
  • Support Clinical Assessment team in the preparation of any audits and Inspections; coordinate collection of documents, meetings etc.
  • Stay up to date with ICH GCP knowledge

Your qualifications

  • First experience within clinical study administration required (CRO, Pharmaceutical, Biotech, Medical Device industry)
  • Knowledge of Documentum or other Document Management System (DMS) is an advantage
  • Fluent English (oral and written), other languages are an asset
  • Strong interpersonal skills and team player abilities
  • Good knowledge of MS Office and interest in working with other IT tools

If this challenge appeals to you, please do not hesitate to apply, through our online portal or via mail. All applications will be treated in strictest confidence and all applicants will receive a response. For any further questions, please contact David la Framboise.

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