Beschreibung
We are looking for a
Trial Document Specialist (m/f)
Reference: -en
Start: 02/17
Duration: 5 MM
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Support Clinical Scientists in the set-up of an eTMF process for assigned studies
- Support Clinical Scientists in the maintenance of trial documentation
- Contribute to the creation/harmonization of templates/guidances, e.g. trial document delivery plan template, document tracking tools, training materials, TMF Quality Control guidances
- Assist in maintaining tracking of trial master file locations (during study and upon archiving)
Your qualifications
- Good knowledge of regulatory requirements and best practices pertaining to trial document management and archiving of clinical trial documentation
- Good organizational and interpersonal skills
- Some knowledge of clinical trial design, execution and operations would be beneficial
Skills:
- Clinical trial assistant