Global Clinical Research Associate

Requirements to candidate 

• experience with bio equivalence clinical trials
• directly supporting clinical trials or RnD
• medical writing (clinical, non-clinical part of the pharmaceutical dossier)
• university degree (medicine, pharmacy or biology)
• excellent written and oral knowledge of English
• computer literacy (MS Office, etc.)
• good communicator, self-organizational, adaptable, flexible, open, accurate and with attention to      detail, fast learner

Main responsibilities

• Support and review of documentation of new clinical trials, clinical trials protocols, designs of the studies, support to Clinical trial applications
• Evaluation of non-clinical and clinical pharmaceutical dossier sections, in particular Modules 2, 4, 5, for established dossiers and within Due Diligence of new projects
• Input to replies to Health Authorities’ Deficiency Letter
• Input to dossier Module 4 & Module 5 (clinical data & BE studies) and other documents (medical writing)