Roles and Responsibilities

• Developing Clinical Study Outlines
• Designing protocols for clinical trials Phase I to IV and for bioavailability /bioequivalence studies
• Preparation of Clinical Study Reports for Phase I to IV clinical trials and Bioavailability/ Bioequivalence studies for submission to regulatory authorities
• Preparation of Common Technical documents (CTD) for Regulatory Authority submission
• Preparation of Manuscript ICF, PIS, IBs and PSUR
• Protocol briefing sessions of clinical operations, statisticians & data management team
• SAE Narrative preparation
• Departmental SOP preparation and revision
• Support to Business Development in preparation of clinical trial proposals
• Feasibility analysis for the clinical trials by discussing with specialists in various therapeutic areas
• Preparing Feasibility questionnaires to support Clinical Operations

Desired Candidate Profile

• Exp: 5-8 yrs.
• Preferred experience in eCTD authoring, protocol, IB, CSR reports, Clinical trials (phase I, II, III, IV)

Apply through this Link