Profile Details

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Hire Vandana B.

India

USD 50 /hr

Freelance ​Senior Compliance Consultant | Clinical Data & Regulatory Documentation

Profile Summary

​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

Subject Matter Expertise

• ★ 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

Services

• Research

Research User Research, Fact Checking, Gap Analysis

Work Experience

Projects Manager

Atos Syntel

September 2015 - March 2024

Education

M.Sc.Biochemistry

Devi Ahilya University of Indore - India

March 1996 - April 1998

Certifications

• Certified Six Sigma Blackbelt

  Grey Campus

  December 2023 - Present