Job Description

Role & responsibilities Literature review, feasibility evaluation and study design for Bioequivalence studies Thorough understanding of national and international regulatory guidance on Bioequivalence Review of clinical study documents of Bioequivalence studies in healthy subjects and patient PK study Clinical study monitoring Knowledge of IPs management Preparation and maintenance of Trial master file Oversee the overall management of Bioequivalence studies Basic understanding of project contract with service providers Ready to take up any other relevant tasks as and when needed