Posted:3 days ago| Platform: Linkedin logo

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Job Summary – Clinical Research (Micro Labs)
Overview:Responsible for independently planning, executing, and managing clinical trials—mainly bioequivalence, but also safety and efficacy studies—ensuring they are completed on time, within budget, and in compliance with regulatory and company standards.Key Responsibilities:Contribute to formulation development.Define clinical strategy (Study designs, Sample size, healthy volunteers or patient studies).Lead and manage BABE studies from planning through execution, data analysis, and reporting.Collaborate closely with team leaders and oversee operational activities.Select and manage CROs, ensuring cost-efficiency, regulatory compliance, and quality.Ensure GCP audit readiness.Work Experience: Minimum 5-7+ years of experience in clinical Research (BABE studies) or associated fields.Knowledge of pharmacy, pharmacokinetics, bioanalysis, statistics and/or IVIVC.Solid knowledge of GCP and worldwide regulatory requirements related to assigned area.Solid medical/scientific writing skills.

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