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Vijaya Reddy

Vijaya Reddy

Aspiring Clinical Trial Assistant | Documentation, Compliance & Regulatory Support

Talent
St. PetersburgMember since July 30, 2026
Clinical Trial Documentation & Subject File Management (Audit-Ready Practices)Trial Master File (TMF) Support & Regulatory RecordkeepingCompliance & Policy AdherenceData Tracking & ReportingProcess Coordination & Workflow ManagementConfidential Data HandlingCross-Functional Team CollaborationMicrosoft Office (Excel, Word, PowerPoint)Adobe AcrobatStrong Attention to Detail & Quality Control
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Clinical Trial Documentation & Subject File Management (Audit-Ready Practices)Trial Master File (TMF) Support & Regulatory RecordkeepingCompliance & Policy AdherenceData Tracking & ReportingProcess Coordination & Workflow Management

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

Skills

Aspiring Clinical Trial AssistantDocumentationCompliance & Regulatory Support

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