Summary
Overview
Work History
Education
Skills
Languages
Websites
Certification
Timeline
Generic

Pallabi Priyadarshini

Bengaluru

Summary

Clinical Data Coordinator with around two years of experience in managing and reconciling clinical data. Proficient in using tools like MediDATA Classic RAVE and RAVE X for discrepancy management and ADMS Tool for data reconciliation. Experienced in conducting thorough data reviews, query management, and vendor reconciliation. Adept at ensuring data integrity throughout the data lifecycle, including DM freeze and lock procedures. A problem-solving enthusiast with a passion for collaboration and continuous growth.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Associate Clinical Data Co-ordinator

IQVIA
Bengaluru
11.2022 - Current
  • Conduct basic data review and quality control procedures, and adhere to all relevant sections of the Data Management Plan.
  • Discrepancy Management using Medidata Classic Rave and Rave X.
  • Perform data reconciliations through ADMS tool and backend check review.
  • Data review through P21 Enterprise and FBT.
  • Identify and report protocol violations.
  • Generated and resolved queries, conducted data cleaning, and performed manual review using Rave listings, along with vendor reconciliation.
  • Test script writing for new edit checks.
  • Handling study migrations and performing migration-related activities, and performing UAT.
  • Communication via emails and calls with the overseas client and vendors in order to resolve the discrepancies and ensure a clean database.
  • DM Review and Freezing of forms.
  • Develop and maintain good communications and working relationships with the CDM team, along with external clients.
  • Meet project objectives, as assigned by Project Lead, Data Team Leads, and Data Operations Coordinator.
  • Supporting the junior team members by guiding them through the project specifics.
  • Maintained TMF and ensured project documents are complete, current, and stored appropriately.

Jr. Drug Safety Associate

Bioclinica
Mysore
04.2021 - 12.2021
  • Enter preliminary and follow-up information from source document into database ArisG.
  • Responsible for performing duplicate searches, processing cases in Triage and Data Entry workflow while maintaining the regulatory timeline, signal detection, and seriousness.
  • Prepare medical narrative and code adverse events using appropriate MedDRA coding.
  • Worked with solicited cases and spontaneous cases. Pregnancy cases, partner cases, and health authority cases.
  • Performed upgrade and downgrade of cases as serious/non-serious while accessing the reported information in the source document.

Education

Master of Technology - Biotechnology

Siksha O Anusandhan University
Bhubaneswar, Odisha
08-2019

Master of Science - Botany

Khallikote University
Brahmapur
08-2017

Bachelor of Science - Botany

Nayagarh Autonomous College
Nayagarh, Odisha
09-2015

12th Standard - Science Education

UNIITECH Residential College
Nayagarh, Odisha
05-2012

10th Standard -

Maharishi Vidya Mandir
Nayagarh, Odisha
03-2010

Skills

  • Medidata Rave and Rave X
  • Managed Study Start-Up
  • Managed Database Lock
  • Discrepancy Review/Query Resolution
  • External Data Reconciliation
  • Database/Edit Check Testing

Languages

Odia
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2

Websites

Certification

  • Training programs in Clinical Trial Management, Pharmacovigilance and Clinical Data Management from Clini India (2021)

Timeline

Associate Clinical Data Co-ordinator

IQVIA
11.2022 - Current

Jr. Drug Safety Associate

Bioclinica
04.2021 - 12.2021

Master of Technology - Biotechnology

Siksha O Anusandhan University

Master of Science - Botany

Khallikote University

Bachelor of Science - Botany

Nayagarh Autonomous College

12th Standard - Science Education

UNIITECH Residential College

10th Standard -

Maharishi Vidya Mandir

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Pallabi Priyadarshini