Job Title

Job Description

Job Responsibilities:
• Analyzes clinical trial protocols and studies, ensuring adherence to regulatory requirements and alignment with strategic objectives, providing recommendations for protocol optimization and enhancement.
• Crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions, employing advanced-level proficiency in standard software tools and systems, adhering to internal procedures, templates, and external standards, regulations, and guidance.
• Troubleshoots complex issues related to clinical data collection, analysis, and reporting, leveraging analytical skills to ensure data integrity, accuracy, and consistency across studies, working under some supervision.
• Assesses and critically analyzes clinical study data within the clinical study rep...