Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
Timeline
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Esha Awale

Summary

Dedicated clinical research professional with extensive experience in centralized monitoring, data review, and remote site management across global clinical trials. Recognized for attention to detail, data analytics capabilities, and proactive communication with cross-functional teams. Adept in ensuring protocol compliance, resolving site-level issues, and delivering insights through study-specific metrics and risk analysis.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Senior Centralized Monitor

IQVIA
04.2024 - Current
  • Manage assigned sites and independently perform Subject Level Data Review (SLDR); support dual roles as required.
  • Conduct remote monitoring visits and assess clinical data accuracy, including eligibility, AEs, labs, endpoints, and SAEs.
  • Execute centralized monitoring per protocol, SOPs, and regulatory guidelines.
  • Analyze and present study-specific data trends; develop actionable insights for stakeholders.
  • Support site performance through metric tracking, COP compliance checks, and risk indicator reviews.
  • Serve as Technical Solution Specialist (TSS) and provide input on scope complexity, turnaround, and resource estimation.
  • Maintain audit readiness through complete and accurate documentation of site-level tools and templates.
  • Provide mentorship to Associate Monitors; conduct trainings and participate in sponsor/study team meetings.

Centralized Monitor

IQVIA
06.2022 - 03.2024
  • Performed centralized monitoring on global clinical trials; evaluated protocol compliance and data quality.
  • Maintained accuracy in systems, databases, and tracking tools for study-specific data.
  • Investigated subject-level data discrepancies and collaborated with CRAs/sites to resolve them.
  • Participated in team meetings and managed follow-ups on outstanding actions and milestones.
  • Contributed to trend analytics and study oversight by identifying early risk signals.

Associate Central Monitor

IQVIA
02.2021 - 06.2022
  • Managed global phase trials, including nephrology and COVID-19 indications.
  • Interacted with sites and CRAs to resolve missing data, query backlogs, and protocol deviations.
  • Prepared i-site packs and maintained study timelines by supporting system updates.
  • Ensured completeness of project documentation and communications.

Centralized Monitoring Assistant

IQVIA
02.2019 - 02.2021
  • Assisted with project documentation, system reports, and study-specific updates.
  • Supported team members with operational tasks and study data maintenance.
  • Supported decision-making by generating comprehensive reports on monitored activities.

Education

Master of Science - Microbiology

Bhavans College
Mumbai, India
01-2018

Bachelor of Science - Microbiology

Patkar Varde College
Mumbai, India
01-2016

Skills

  • Proficient in EDC, TMF, IXRS, CTMS, and other clinical trial systems
  • Strong Microsoft Office skills (Excel, Word, PowerPoint)
  • Excellent planning, time management, and attention to detail

Accomplishments

  • Consistently recognized within IQVIA through various internal awards for exceptional performance since the start of my career, including Spotlight, Ovation, and Bronze awards.
  • Selected to attend Investigator Meeting in Melbourne, Australia for a global clinical trial study.
  • Participated in slide review sessions with sponsor team to ensure alignment of trial objectives and site-level data.

Certification

  • Fundamental GCP Accreditation Exam (English) 4.0, 2020
  • Lean Practitioner MOOC Training
  • Weekend Sandwich Course on Food Safety (QCI Certified) – 2016
  • Workshop on Bioinstrumentation – 2017

Languages

English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)

Timeline

Senior Centralized Monitor

IQVIA
04.2024 - Current

Centralized Monitor

IQVIA
06.2022 - 03.2024

Associate Central Monitor

IQVIA
02.2021 - 06.2022

Centralized Monitoring Assistant

IQVIA
02.2019 - 02.2021

Master of Science - Microbiology

Bhavans College

Bachelor of Science - Microbiology

Patkar Varde College

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Esha Awale