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