Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Hobbies and Interests
Timeline
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Moushumi Das

Bengaluru

Summary

Professional Clinical Data Analyst with five plus years of experience, eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Motivated to learn, grow, excel, and amplify my technical skills to continue making a difference in the lives of patients in the field of Clinical Data and Research.

Overview

5
5
years of professional experience

Work History

Clinical Data Analyst II

Parexel International
Bengaluru
04.2023 - Current
  • Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock, e.g. query management, manual/SAS listing reviews and external vendor data reconciliation
  • Good knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, ClinBase, Elluminate.)
  • Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines
  • Lead/perform User Acceptance Testing on clinical database setups
  • Review protocols and EDC Entry Screens if required
  • Provide input on the data management timelines and coordinate the DM operational activities during database set up
  • Track and review CRFs. Support data entry where required
  • Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines
  • Perform/Lead functional QC activities on databases and/or patient data, as per business needs
  • Act as Mentor for other clinical data analysts.

Clinical Data Analyst I

Labcorp Drug Development (Formerly known as Covance)
Bengaluru
04.2019 - 04.2023
  • Review and action queries on an ongoing basis and update database appropriately
  • Perform UAT (User Acceptance Testing) according to Validation Plan for applicable Data Management systems
  • Issue queries for data points that exhibit unacceptable discrepancies as appropriate and support Quality control checks for the trial
  • Reconcile project files, reports, listings and other documents generated in data management against the EDC database for accuracy and completeness of data management processes
  • Perform all tasks to relevant Covance and/or Sponsor SOPs, ICH or other regulatory guidelines in Data Management
  • Conduct quality control of CRF vs Database, communicate issues identified during data review to the Lead CDA/Data Manager
  • Perform data review for different external and local data types as per the scheduled data transfers and record the data discrepancies involving both the electronic CRF and the vendor data
  • Perform decommissioning and archiving activities of the close out phases of the studies

Education

Master of Science - Biotechnology

Padmashree Institute of Management And Sciences
Bengaluru, Karnataka
01-2018

Bachelor of Science - Biotechnology

St. Edmund's College Shillong
Shillong, Meghalaya
01-2016

Skills

  • Clinical Trails
  • Clinical Data Management
  • Data Analysis, Data Cleaning
  • User Acceptance Testing
  • Microsoft Excel, Microsoft Office
  • Therapeutic Areas
  • Clinical Databases - InForm, Rave, Veeva, Clinbase, Elluminate
  • Data validation
  • Critical thinking, easily adaptable
  • Teamwork

Accomplishments

    Did commendable job in performing Data Entry and Proc QC for a particular project within the assigned time and given my full efforts in reducing the data entry backlog. Got awarded and recognized for the same.

Languages

  • English
  • Hindi
  • Bengali

Hobbies and Interests

  • Food blogging
  • Travelling
  • Theatre plays

Timeline

Clinical Data Analyst II

Parexel International
04.2023 - Current

Clinical Data Analyst I

Labcorp Drug Development (Formerly known as Covance)
04.2019 - 04.2023

Master of Science - Biotechnology

Padmashree Institute of Management And Sciences

Bachelor of Science - Biotechnology

St. Edmund's College Shillong

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Moushumi Das