Summary
Overview
Work History
Education
Skills
PERSONAL DETAILS
Languages
Accomplishments
Certification
Timeline
Generic
Pradeeksha

Pradeeksha

Bangalore

Summary

Dynamic Clinical Data Specialist with extensive experience at IQVIA, excelling in data management and project oversight. Proven track record in data validation and effective communication, ensuring high-quality clinical trial outcomes. Skilled in Rave and electronic data capture, adept at resolving discrepancies and leading vendor reconciliations to enhance data integrity.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Clinical Data Specialist

IQVIA
Bangalore
05.2022 - 05.2025
  • Performed clinical data entry and verification, aided in data entry, and designed edit checks.
  • Performed database lock and freeze activities.
  • Reported on project status to management, generated weekly status, and logged reports.
  • Overseas data management tasks, ad-hoc activities, and maintaining the project tracker.
  • Identified discrepancies between collected data and original source documents; resolved issues by working with investigators or other staff members.
  • Reviewed CRF for data completeness, accuracy, and consistency using SAS listings, checks, and queries.
  • Worked as a POC in studies and collaborated with statistical. Programmers and the project management team are to meet data management deliverables.
  • Worked as a vendor reconciliation lead for external vendors such as SAE, Imaging Adjudication, PK, and Non-PK.
  • Performed UAT within Rave and QC of CDM activities.
  • Participated in RECIST watch to support the physician in the medical review.
  • Performed zero count listing and never-fired checks in both the UAT environment and with datasets.
  • Coordinated database lock activities and tracked milestones throughout the study duration.

Assistant Clinical Data Analyst

Fortrea
Bangalore
08.2020 - 05.2022
  • Broad knowledge of data management processes, including EDC experience. E.g.: Medidata RAVE, Classic Rave.
  • Responsible for query generation, resolution, and tracking all queries through the data issue log.
  • Reviewed CRF data for accuracy and consistency as per DMP and guidelines, and resolved data discrepancies.
  • Performed manual listings, SAS listings, and EDC SAS checks to ensure quality, and integrity of data were maintained.
  • Performed vendor data reconciliation for multiple data sets, e.g., laboratory data, PK, non-PK, e-PRO.

Education

Post Graduate Diploma in Clinical Research -

Avigna Clinical Research Institute
Bangalore
03-2020

M.sc Zoology -

Bangalore University
Bengaluru
05-2017

Skills

  • Rave, Sapphire, Calyx, DSR, ADMS, emticine, Signant Health, PRP, and Spotfire
  • Clinical data management
  • Project management
  • Effective communication
  • Problem solving
  • Data validation
  • Time management
  • Electronic data capture
  • Clinical trials

PERSONAL DETAILS

Nationality : Hindu

Date of birth: 04/07/1995

Marital status: Married

Gender: Female

Languages

kannada
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Telugu
Proficient (C2)
C2

Accomplishments

  • Received multiple 'Spot light ', 'Ovation' awards for studies handled in IQVIA.
  • Received multiple recognitions for the performance from the study, PDMS, in Fortrea
  • I have been a part of 8 interim analyses, 4 safety locks, and 3 final database lock studies in IQVIA
  • Successfully performed interim lock activities for 5 studies in Fortrea.

Certification

  • Therapeutic areas: oncology, immunology, and respiratory
  • Database tools: Rave (production and UAT), Classic RAVE, and Spotfire
  • MS Office: Word, PowerPoint, and Excel

Timeline

Clinical Data Specialist

IQVIA
05.2022 - 05.2025

Assistant Clinical Data Analyst

Fortrea
08.2020 - 05.2022

Post Graduate Diploma in Clinical Research -

Avigna Clinical Research Institute

M.sc Zoology -

Bangalore University

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