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Location: Bengaluru, Karnataka, India
Job ID: R-236736
Job Type: Full-Time
This role ensures the effective execution of study delivery processes across clinical studies from start-up to reporting. The Clinical Research Associate serves as the main contact for study documentation and supports the production, compliance, and management of clinical-regulatory documents, ensuring high-quality delivery in accordance with company policies and regulations.
Execute study delivery processes through development of study report tools and maintenance of the study delivery system.
Deliver centrally managed study management services across clinical studies from start-up to reporting.
Serve as the main contact and liaise with the Document Management group until the Clinical Study Report is finalized.
Initiate and maintain production of study documents, ensuring template and version compliance.
Create or import clinical-regulatory documents into the Global Electronic Library according to the Global Document List.
Monitor administrative tasks, audits, and regulatory inspections according to company policies.
Essential: Bachelor’s degree in a relevant discipline; experience in study management within a pharmaceutical or clinical background; knowledge of relevant legislation and developments in clinical development and study management.
Desirable: Advanced degree; professional certification; understanding of multiple aspects within study management.
Experience & Skills
Experience in study management, documentation handling, and compliance within clinical trials. • Strong organizational, communication, and interpersonal skills.
Attention to detail and ability to work independently.
Bengaluru, Karnataka, India
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