プロフィール詳細

プロジェクトを作成

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Vandana B.に依頼

India

Freelance ​Senior Compliance Consultant | Clinical Data & Regulatory Documentation

プロフィール概要

​Expertise in Clinical Data Integrity & Regulatory Excellence ​Accomplished professional with over 18 years of experience in Clinical Data Management and Trial Master File (TMF) management. I specialize in navigating the complexities of regulatory compliance to ensure clinical trial documentation is audit-ready, accurate, and fully aligned with global standards. ​Throughout my career, I have bridge the gap between technical data management and stringent regulatory requirements. My approach focuses on maintaining high-quality data lifecycles while mitigating compliance risks through meticulous oversight and strategic quality assurance

専門分野

• ★ Clinical Trials
• ★ Regulatory Affairs
• ★ Clinical Trial Documentation
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Regulatory Writing
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Investigational New Drug (IND) Application Writing

サービス

• Research

Research User Research, Fact Checking, Gap Analysis

職務経験

Atos syntel private limited

- 現在

Data Entry operator

Bhopal Memorial Hospital & Research Centre

12月 2000 - 4月 2024

Projects Manager

Atos Syntel

9月 2015 - 3月 2024

QA QC Coordinator

National AIDS Research Institute

6月 2006 - 5月 2015

学歴

M.Sc.Biochemistry

Devi Ahilya University of Indore - India

3月 1996 - 4月 1998

M.Sc (Biochemistry)

Devi Ahilya Vishwavidyalaya

3月 1996 - 4月 1998

Post Graduation Diploma in Computer Science (Computer Science )

Devi Ahilya Vishwavidyalaya

7月 1996 - 5月 1997

B.Sc. (Biology )

Devi Ahilya Vishwavidyalaya

3月 1993 - 3月 1996

認定資格

• Certified Six Sigma Blackbelt

  Grey Campus

  12月 2023 - 現在