About

The Regulatory Documents Assistant will establish and maintain the Sponsor electronic or paper Trial Master File (TMF) throughout the life of the trial and will perform record review of essential documents for accuracy and quality according to ICH-GCP. The Regulatory Documents Assistant is also responsible for the set-up of the Investigator’s Study File (ISF) binders.  RESPONSABILITIES Participates in the development of the TMF structure. Participates in the development of the electronic TMF …