Responsible for overseeing the planning, execution, and completion of clinical studies across multiple phases. The role involved managing all operational aspects of clinical trials, ensuring compliance with regulatory requirements, and coordinating with internal and external stakeholders to achieve project milestones. As a Clinical Study Lead I worked closely with cross-functional teams, including clinical operations, regulatory affairs, and data management, to ensure the smooth conduct of clinical trials in line with company goals and timelines.

Key Responsibilities:

Study planning and execution

Lead a cross-functional clinical study team

Ensure studies are conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, and local and international regulatory requirements.

Oversee the preparation and submission of regulatory documents to ethics committees and competent authorities.

Ensure studies are conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, and local and international regulatory requirements