Vijaya Reddy
Aspiring Clinical Trial Assistant | Documentation, Compliance & Regulatory Support
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About
Detail-oriented professional with hands-on experience in clinical trial documentation, regulatory recordkeeping, and compliance gained at Hetero Drugs Ltd, a pharmaceutical manufacturer in India. Skilled in maintaining audit-ready subject files, ensuring documentation accuracy, and supporting cross-functional work in structured, regulated environments. Relocated to the United States after completing the immigration process; now pursuing a full transition into clinical research operations as a Clinical Trial Assistant, applying transferable strengths in documentation management, confidentiality, and process coordination.
Authorized to work in the United States.
Experience
Human Resources Executive — Documentation & Compliance Support - Hetero Drugs Ltd - India
Assisted with maintaining and organizing clinical trial documentation, ensuring records were complete, accurate, and properly filed in support of regulatory and audit requirements.
- Organized and maintained subject files in an orderly, audit-ready manner, supporting recordkeeping practices consistent with Trial Master File (TMF) standards.
- Supported compliance-related activities by ensuring proper documentation and adherence to internal and regulatory policies.
- Maintained and audited employee records, ensuring accuracy, completeness, and compliance with organizational policies.
- Coordinated documentation processes, including background verification and employee record management.
- Handled high volumes of confidential data with strong attention to accuracy and data integrity.
- Collaborated with cross-functional teams to ensure timely execution of processes and resolution of issues.
- Managed full-cycle recruitment, including candidate screening, interview coordination, and onboarding.
- Tracked and reported recruitment metrics, maintaining structured data for management insights.
Relocation to the United States - United States
Relocated to the United States and completed the immigration process. During this period, focused on family transition and preparing for re-entry into a professional career in the U.S., with continued interest in clinical research operations.
Education
Bachelor of Technology - Electronics and Communications Engineering - JNTU University

