Clinical Research Associate-BA/BE studies

Job description: Clinical Research Associate/ Project Manager– Bioequivalence (BE) Studies

Job Summary

The Clinical Project Manager (CPM) is responsible for the end-to-end management of sponsor-led bioequivalence (BE) studies conducted at Contract Research Organizations (CROs). The CPM ensures studies are delivered on time, within budget, and in compliance with regulatory requirements including U.S. Food and Drug Administration, European Medicines Agency, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines.

The role serves as the primary liaison between the sponsor and CRO, overseeing study planning, execution, data review, reporting, and submission readiness.

Key Responsibilities

1. Study Planning & Start-up

• Lead cross-functional study planning activities (Clinical, Regulatory, QA, Bioanalytical, PK, Data Management).
• Deve...