Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
Timeline
Generic

HARSHIL SARDHARA

Jersey City

Summary

Results-driven healthcare and clinical research professional with 3 years of pharmaceutical research experience. Proficient in data analysis, clinical trial design, and regulatory compliance, including updating Trial Master File (TMF) records. Skilled in statistical modeling, population analytics, and cross-functional collaboration to drive impactful healthcare research and innovation. Possess profound knowledge of ICH guidelines and GCP, ensuring compliance in clinical research and regulatory affairs. Known for adaptability, problem-solving, and fostering collaborative environments to achieve impactful results. Experienced with advanced research methodologies, statistical analysis, and experimental design; utilizes comprehensive knowledge to drive meaningful results in diverse research settings. Demonstrates a track record of producing high-quality, peer-reviewed research that informs and advances the scientific community.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Senior Research Associate

Piramal Pharma Solutions Pvt. Ltd
08.2019 - 10.2022
  • Analyzed and interpreted data from invitro studies on NCEs, generating insights that contributed to $20M in revenue while ensuring diverse sample representation.
  • Developed and validated analytical methods for UGT inhibition and kidney binding assays, applying epidemiological principles to secure a $180K project.
  • Collaborated cross-functionally with Principal Investigators and facilitated audits, ensuring diverse perspectives informed research approaches.
  • Led a team of 5 members, mentoring 4 interns and ensuring the delivery of high-quality results and documentation.
  • Produced detailed epidemiological reports and developed SOPs for ADME and cell-based assays, incorporating data visualization techniques to highlight population differences.
  • Maintained mammalian cell lines and executed permeability experiments critical to new project development.
  • Developed data-driven experimental protocols through statistical analysis of trial-and-error methods, ensuring protocols captured diverse population responses, while updating and maintaining accurate records in the Trial Master File (TMF) to support regulatory compliance and data integrity.

Education

Master of Public Health - Biostatistics and Epidemiology

Monroe University
New Rochelle, NY
08.2025

Masters of Science - Microbiology

Sardar Patel University
03.2019

Bachelors of Science - Microbiology

Saurashtra University
03.2017

Skills

  • Clinical project coordination
  • Regulatory compliance expertise
  • Statistical analysis proficiency
  • Experience with statistical analysis tools
  • Training and mentoring
  • Documentation skills
  • Laboratory techniques
  • Research and analysis
  • Experimental design

Accomplishments

  • Supervised team of 5 staff members.

Certification

  • Certificate of Achievement – Psychological First Aid (PFA) Online, organized by the National Child Traumatic Stress Network (NCTSN) (June 2025)
  • Certificate of Achievement – Trauma Training for Early Childhood (TTEC), organized by the National Child Traumatic Stress Network (NCTSN) (May 2025)
  • Certified Medical Laboratory Technologist, (Gujarat Vocational Training, July 2020)

Languages

English
Professional Working
Hindi
Native or Bilingual

Timeline

Senior Research Associate

Piramal Pharma Solutions Pvt. Ltd
08.2019 - 10.2022

Masters of Science - Microbiology

Sardar Patel University

Bachelors of Science - Microbiology

Saurashtra University

Master of Public Health - Biostatistics and Epidemiology

Monroe University

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