Summary
Overview
Work History
Education
Skills
Certification
Awards
Internship
Timeline
Generic
Greeshma Suresh

Greeshma Suresh

Specialist Clinical operations
Bangalore

Summary

Clinical research and healthcare professional with 7 years of diverse experience in Clinical operations, clinical trial management, regulatory affairs and pharma market access. Proven track record of effectively managing clinical trials and collaborating closely with clinical teams to address discrepancies, conduct data reconciliation, and support all phases of clinical studies from initiation to close-out. Skilled in developing global pricing and reimbursement strategies, including managing net price databases, providing pricing insights. Proficient in navigating regulatory agencies such as Health Canada, TGA (Australia), FDA (USA), and EMA (European Medical Agency) to ensure timely submissions and approvals.

Overview

7
7
years of professional experience
4033
4033
years of post-secondary education
2
2
Certifications
5
5
Languages

Work History

Specialist - Clinical Operations

IQVIA
01.2022 - Current
  • Perform clinical data scouting from ct.gov and EudraCT and prepares draft to update in HTA.
  • Involved in keeping the primary and secondary endpoints and COA instruments field free of errors and missing values and have maintained the subject data in compliance with the regulatory standards.
  • Experience on managing regulatory agencies like Health Canada, TGA (Australia), FDA (US) and EMA (European Medical Agencies).
  • Managing Pricing Insights, Pricing & Reimbursement information database, Price Margin calculator, Net price database.
  • Participate and contribute to departmental process improvement initiatives.
  • Key role in automating the data entry for clinical trials and other regulatory agencies.

Clinical Specialist

IQVIA
03.2020 - 01.2022
  • Provide monitoring support for end-to-end activity (Study set-up phase, conduct phase and Close-out phase) to the project management team for designated studies which includes performing tasks that are completed according to service level agreements (SLAs) and within project timeline.
  • Performs daily monitoring of the studies which include preparation of reports and sharing to the sponsor team.
  • Resolves the queries raised on Newlims and Qlims query manager for the protocols assigned on daily basis.
  • Regular communication with the CRA's and pharmaceutical clients for study status update/query resolutions.
  • Performs other activities like Data Reconciliation, close out activity memo preparation for all protocols.
  • Also performs ad-hoc activities like QC check for site loading.
  • Enhanced working relationships by participating in team-building activities.

Clinical Process Associate

IQVIA
09.2018 - 03.2020
  • Internal Trainer for LTMS team and provide trainings for the new joiners.
  • Loading the newly awarded studies into LTMS database.
  • Allocation of work to the entire team on daily basis.
  • Monitoring on-time release of patient laboratory report to sites.
  • Perform site closeout activities like sending close out memo to the sites, action on pending kits or samples remaining.
  • Performing Expired Kit Notification activities including memo preparations, faxing of memos to sites and Escalations.
  • Query management and other project management activities.

Clinical Process Coordinator

IQVIA
03.2018 - 09.2018
  • Resolve queries on daily basis in Infosario and LTMS database.
  • Participate in creating and updating new clinical trials on LTMS.
  • Update the visit details into LTMS according to countries participating in the study.
  • Perform QC to ensure quality and accuracy of the format and technical information of the request, and the identity of the External User for whom access is being requested.

Education

Postgraduate - Biotechnology

A.J College of Science And Technology
Trivandrum, India
11-2017

Graduate - Botany and Biotechnology (Multimajor)

Mar Ivanios College
Thiruvananthapuram, Kerala
04-2014

Skills

  • Clinical Trial management, monitoring

  • Data Reconciliation

  • Good undertanding of COA Instruments

  • Clinical Trials and experience in working closely with clinical teams to resolve discrepancies, conduct data reconciliation, and support all phases of clinical studies from initiation (start-up) to close out

  • Good communication skills

Certification

Skill Development in Food safety: Hazard Analysis Critical Control Point (HACCP), ERRC, IICT, IGNOU, 11/2017

Awards

  • Quintiles global Recognition - Applause Award, Commitment and Teamwork, 2018
  • Quintiles global Recognition - Applause Award, Commitment and Teamwork, 2020

Internship

Centre:  Rajeev Gandhi Centre for Biotechnology (RGCB), Thiruvananthapuram, Kerala, India

Titile: Project Trainee

Year: Apr 2017 to Jul 2017

Techniques handled:

Culturing of animal cells using different cell-lines, Performing various techniques like DNA-RNA isolation, cell manipulation, transformation, Agarose gel electrophoresis, SDS PAGE, Isoelectric focusing, etc., Handling of various equipments like Laminar Air Flow, Autoclave, Gel electrophoretic apparatus, Centrifuge, Rotavapour, PCR, UV Spectrophotometer etc

Timeline

Specialist - Clinical Operations

IQVIA
01.2022 - Current

Clinical Specialist

IQVIA
03.2020 - 01.2022

Clinical Process Associate

IQVIA
09.2018 - 03.2020

Clinical Process Coordinator

IQVIA
03.2018 - 09.2018

Postgraduate - Biotechnology

A.J College of Science And Technology

Graduate - Botany and Biotechnology (Multimajor)

Mar Ivanios College

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Greeshma SureshSpecialist Clinical operations