Summary
Overview
Work History
Education
Skills
Languages
Certification
Accomplishments
Timeline
Generic

Ghousia Ahemady

Summary

Detail-oriented Document Specialist with expertise in eTMF management, regulatory documentation, and quality control within clinical research.

Proficient in Veeva Vault Clinical, with a strong track record of achieving less than 1% error rates and exceeding productivity benchmarks (greater than 120%). Seeking a role to drive operational excellence and enhance regulatory compliance in clinical trials. Reliable in completing quality work, and exceeding expectations.

Overview

1
1
year of professional experience
1
1
Certification

Work History

Document Specialist

IQVIA
Bengaluru
11.2023 - Current
  • Managed the eTMF system to ensure accuracy, completeness, and timely submission of essential documents.
  • Conducted quality control (QC) checks on eTMF submissions, maintaining an error rate, Of less than 1%.
  • Reviewed and managed Essential Document Lists (EDLs), ensuring compliance with ICH-GCP, regulatory standards, and client requirements.
  • Consistently meet daily targets and KPIs, ensuring high performance and adherence to departmental goals.
  • Awards: Received the IQVIA Impact Award for exceptional performance and productivity (greater than 120% target achievement).

Education

Master of Science - Biotechnology

Dayananda Sagar University
Bengaluru
01-2023

Bachelor of Science - Biotechnology

St. Joseph's Degree College
Kurnool
01-2021

GED -

Sri Chaitanya College
Kurnool
01-2017

Skills

  • eTMF (Electronic Trial Master File) management
  • Veeva Vault Clinical Expertise
  • Quality control and compliance
  • Good Documentation Practices (ALCOA)
  • ICH-GCP Compliance
  • Essential document review and management
  • Data accuracy
  • Functional Team Collaboration
  • Time management and prioritization

Languages

Urdu
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
telugu
Proficient (C2)
C2

Certification

  • Advanced Program in Clinical Research and Management - Clini India - February 23
  • Workshop on CRISPR/Cas gene editing: a potential tool in therapy and diagnostics
  • Hands-on training workshop on 'Animal Cell Culture and Its Role in Research and Industry'
  • Participated in the National Conference on 'Contextual Approaches in Applied Microbiology'

Accomplishments

Received the IQVIA Impact Award for exceptional performance and productivity (greater than 120% target achievement)

Timeline

Document Specialist

IQVIA
11.2023 - Current

Master of Science - Biotechnology

Dayananda Sagar University

Bachelor of Science - Biotechnology

St. Joseph's Degree College

GED -

Sri Chaitanya College

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Ghousia Ahemady