Summary
Overview
Work History
Education
Skills
Accomplishments
Projects
Languages
Strengths
Timeline
Generic

POOJA RADHA

Bengaluru

Summary

Dynamic professional with extensive experience at IQVIA, excelling in project management and risk assessment. Proven track record in ensuring regulatory compliance and data integrity, while enhancing operational efficiency. Adept at stakeholder management, I successfully led multiple projects, achieving a 95% audit success rate through innovative strategies and collaboration with cross-functional teams.

Highly observant and vigilant with experience in monitoring various environments. Possess strong analytical skills, adept at identifying irregularities, and able to act promptly during emergency situations. Known for maintaining safety standards and ensuring compliance with set protocols. Successfully ensured smooth operations in past roles by enforcing rules and regulations effectively.

Overview

4
4
years of professional experience

Work History

Central Monitor

IQVIA
Bangalore
08.2024 - Current
  • Manage the operational insights of the assigned projects and complete the study metrics trend.
  • Knowledge and indepth analysis of patient data using clinical tools such as veeva vault, oracle siebel CTMS, eTMF tool, RAVE(EDC), Pro tools(Y-prime), labcorp lab link, clin base, calyx and ALMAC(IXRS).
  • Managed multiple projects simultaneously while meeting tight deadlines without compromising quality standards.
  • Early identification of site-level issues occurring during study conduct is responsible for identifying and highlighting the risk.
  • Collaborate with the project management team in the development and implementation of study management plans, tailored tools and templates, and study TMP to ensure high quality and integrity of the study.
  • Provide inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, and workload projections.
  • Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol, and adherence to applicable regulations.
  • Provided study performance updates from a global to local scale team to COL of the entire site lifecycle from activation to close out.
  • Performed study close out of the complete study remotely.
  • Managed the operational insight, ensuring precision tracking, filing and regulatory compliance.
  • Participate in study team meetings/Project Kick off meetings and interaction with cross functional staff to verify information.

Research Associate

Lupin Limited
Pune
12.2023 - 05.2024
  • Company Overview: Lupin is driven by science, inspired by patients
  • Designated as a research associate in the bioanalytical lab (Large Molecule).
  • Supporting regulatory surveillance group for evaluation and implementation of regulatory CAPA as per relevant guidelines.
  • Performing site qualification, site initiation, monitoring in accordance with regulatory and ICH-GCP guidelines.
  • Performing investigational product inventory, reconciliation and reviews storage.
  • Planning/hosting the internal audits (Facility and study), vendor audits and vendor assessment/Evaluation.
  • Perform data collection and a variety of statistical analyses using Microsoft Excel.
  • By working with senior team to develop innovative methods and learning models for documentation in GLP regulated lab, I contribute to the lab's ability to maintain compliance, uphold data integrity, and demonstrate a commitment to quality and excellence in research.
  • Knowledge of GCP, GLP, ICH guidelines and FDA regulations regulatory.
  • Lupin is driven by science, inspired by patients

Research Associate

Syngene International Limited
Bengaluru
04.2021 - 11.2023
  • Company Overview: Syngene is an innovative, led contract research, development, and manufacturing organization.
  • Designed as a research associate in a bioanalytical laboratory (GLP certified and IS/ISO/IEC 17025:2017 ACC lab), I implemented method validation and study sample analysis for PK and immunogenicity using ligand binding assay by SMP and MSD method, as per regulatory guidelines.
  • Coordinating with QA and assisting with compliance of study.
  • Good knowledge in data integrity (ALCOA+) principle Worked closely with a team of research scientists and analysts to improve the statistics given to sponsors with auditing by 95%.
  • Archival of study documentation after completion of the study.
  • Collaborating with quality assurance team to ensure that documentation practices align with GLP guidelines.
  • Syngene is an innovative led contract research, development and manufacturing organization

Education

Master of science - Life Science

Dayananda Sagar University
Bengaluru
04.2021

Bachelor of Science - Life Science

Dayananda Sagar University
Bengaluru
11.2018

Skills

  • GLP
  • Project Management
  • Study management
  • Risk assessment
  • Data integrity
  • Regulatory compliance
  • GCP
  • Stakeholder management
  • Operations management

Accomplishments

  • Spot Award, 03/30/23, I was honored to receive a spot award from Syngene International Limited in recognition of my significant contributions during an audit.
  • Ovation Award received for the iqvia impact program. Recognizing my significant contribution to the CMS-FSP process.
  • Quality improvement through trend detection enhanced trial quality by detecting trend outliers in IMP, Sample and e-pro management
  • Top performer of the month, 05/16/23, for consistently producing high-quality data within sponsor deadline constraints

Projects

Production and extraction of bacterial pigments from beetroot, grapes, betel leaves, orange, 2020 - 2021, Dayananda Sagar University, The academic research project focuses on production and extraction of bacterial pigments from various sources. The main outcome of the study is the identification of novel and potent pigment-producing microorganisms, particularly bacteria, that can produce carotenoids on cost effective and renewable substrates in significant quantities. Successful outcome of my work was development of sustainable and cost effective methods for pigment production using microbial strains on renewable substrates and the findings have implication for various industries, including food, pharmaceuticals, and cosmetics that rely on pigments for various application. Additionally, the study highlights the importance of exploring alternative and environmentally friendly approaches for pigment production.

Languages

  • Kannada
  • English
  • Hindi

Strengths

  • Leadership, In a team of 3 I took the initiative and led the team to analyse 5000 samples of cancer patients in less than 3 months.
  • Delivering Results, Focus on the key inputs and deliver them with the right quality and in a timely fashion.

Timeline

Central Monitor

IQVIA
08.2024 - Current

Research Associate

Lupin Limited
12.2023 - 05.2024

Research Associate

Syngene International Limited
04.2021 - 11.2023

Master of science - Life Science

Dayananda Sagar University

Bachelor of Science - Life Science

Dayananda Sagar University

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POOJA RADHA