Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
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Dr. Roshni Sharma

Dr. Roshni Sharma

New Delhi

Summary

Clinical Research Professional with 6+ years of experience managing WHO-sponsored, multi-country clinical trials in maternal and child health. Currently serving as Clinical Research Coordinator (equivalent to CTM as per WHO/THSTI grading framework), leading a 50+ member team at India's largest government hospital. Skilled in end-to-end trial execution, regulatory compliance (ICH-GCP), SAE reporting, data oversight, and stakeholder coordination. Proven track record in timely trial execution, quality assurance, and scientific publication.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Clinical Coordinator

THSTI
09.2022 - Current
  • Led cross-functional project teams of 50- 55 members
  • Coordinated WHO and ICMR clinical trials, ensuring compliance with regulatory standards and protocols.
  • Developed training materials and conducted workshops for staff on trial procedures and best practices.
  • Optimized resource allocation by regularly monitoring clinic operations and adjusting staffing levels as needed.
  • Boosted project efficiency by 20% through process improvements
  • Monitored budgets, reducing project costs by 20%
  • Managed participant recruitment strategies to enhance enrollment efficiency and retention rates.
  • Developed strategic plans to enhance study efficiency and participant recruitment efforts.

Clinical Research Officer

THSTI
12.2019 - 08.2022
  • Led participant tracking and retention activities for an observational clinical research study; despite 70% of subjects becoming untraceable after COVID, deployed systematic re-engagement approaches to secure a 90% overall follow-up rate and deliver the study within established timelines.
  • Streamlined research processes for improved efficiency and reduced project timelines.

Research Scientist

VMMC & Safdarjung Hospital
04.2019 - 11.2019

1. Improved project enrolment rates to 80% by redesigning and implementing effective recruitment strategies, addressing earlier operational gaps.

2. Led research projects on disease pathology, contributing to advancements in treatment protocols.

Data Coordinator

ICMR
11.2018 - 03.2019

1. Oversaw end-to-end operations for a multi-site study spanning 5 sites in 3 districts, integrating primary, secondary, and qualitative data collection methodologies and delivering the planned 1-year study in just 4 months through optimized site coordination.

2. Conduct quality control activities to collect valuable insights and data for project evaluation.

Education

Master of Science - Public Health

KLE University
Jammu
01-2014

Master of Science - Public Health

KLE University
Belgaum, India
01-2018

Skills

  • Project Management
  • Clinical Trial Monitoring
  • Staff scheduling
  • Developing training programs
  • Regulatory Compliance
  • Risk Management
  • Team Leadership
  • Budgeting and Cost Control
  • Stakeholder Communication

Accomplishments

    Ist Prize in medical exhibition organized by KLE University, Belagavi

    Received National Health Award-2020

Certification

Healthcare Research Fundamentals by NIE- ICMR

Good Clinical Practice by NIDA

Design and Conduct of Clinical Trial by John Hopkins University

Timeline

Clinical Coordinator

THSTI
09.2022 - Current

Clinical Research Officer

THSTI
12.2019 - 08.2022

Research Scientist

VMMC & Safdarjung Hospital
04.2019 - 11.2019

Data Coordinator

ICMR
11.2018 - 03.2019

Master of Science - Public Health

KLE University

Master of Science - Public Health

KLE University
Dr. Roshni Sharma