Summary
Overview
Work History
Education
Skills
Accomplishments
Custom
Custom
Custom
Timeline
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Indraja M

Bangalore

Summary

Seeking a challenging position in the field of Clinical data Management, where my existing skills can be utilized, my fast learning and the ability to take on new challenges can be used, and offers me professional growth while being resourceful, innovative and flexible for the welfare of mankind.

Professional Summary

1.Strong knowledge in Drug Development Process and Clinical Trials.

2.Have a good knowledge on ICH-GCP guidelines.

3.Ability to handle the Veeva volute, IPD, missing labs (AB, PK and Q2 and INVICRO).

4.Strong knowledge and handling experience of multiple Case Report Forms (CRF).

5Have a good knowledge and experience in handling of Data Management Activities.

6.Flexibility and Adaptability to changing environments. Keen desire and willingness to learn new technologies and processes.

7.Demonstrated capacity to work with dedication and involvement.

8.Strong communication and presentation skills.

9.Able to work closely with all levels of management.

10.Have a good knowledge on medical terminologies.

Overview

2
2
years of professional experience

Work History

Clinical Data Review

IQVIA
Bangalore
10.2022 - Current
  • Worked in early oncology portfolio as clinical data review with 1.9 years of hands on experience in Medidata rave and experienced in various data management activities like Query Management, Manual listings, SAS listing, CDR checks, IPD reconciliation, vendor reconciliation and Manual review and participated in database lock activities.

  • Worked on Conduct and Close-out review activities

  • Performed data management activities to ensure accurate, consistent, and complete clinical databases.

  • Task Lead for laboratory, bioimaging and review of Adverse Event and Concomitant Medication listings.

  • Run daily QCT report for track of open, closed and answered queries and run routine reports necessary.

  • Collaborated with study team for various activities and highlighted issues and concerns regarding studies

  • Quality Review performed identified all issues and proposed resolution.

  • Performed Data Access Testing and User Access Testing (UAT) to ensure accuracy of the database.

  • Resolved issues within RAVE database & data entry group, created patient record in UAT for better understanding.

  • Responsible for reviewing CRF data for accuracy and consistency as well as identity to resolve data discrepancies.

  • Performed vendor reconciliation, IPD reconciliation as a monthly review activity.

  • Knowledgeable with Clinical trial methodologies, medical terminology and ICH/GCP guideline.

  • Familiar with creating and review process of CRF design, edit checks, study protocol.

  • Serve in the role of backup to other reviews.

  • Ensured timely updates to project tracker.

  • Prepare presentations for the study meetings related to process and relatable knowledge transfers.

  • Familiar with Clinical research guidelines, MEDRA and WHOART dictionaries.

  • Attended project team meetings and provided feedback to Line manager and Data Team Lead on any challenges/issues for all the study related activities.

Education

Bachelor of Pharmacy (B.Pharm) -

Al-Ameen College of Pharmacy
Bangalore
11.2021

12th Science -

Sri Chaithyana PU College
Bangalore
05.2017

10th -

Nazareth School
Bangalore
05.2015

Skills

  • Veeva vault
  • RECIST 1:1
  • Excel,Word and PowerPoint
  • Attention to Detail
  • Database Management
  • Medical terminology proficiency
  • Communication skills
  • Time management
  • Project Management

Accomplishments

  • Secured scholarship from Bayer company
  • Received Recognition award for Data review and cleaning activity
  • Received ovation for Data Base lock
  • Awards in college for participation in webinars, fest competitions, sports day competitions

Custom

  • English
  • Hindi
  • Telugu
  • Kannada

Custom

  • Playing badminton
  • Pencil sketch
  • Reading novels
  • Dancing

Custom

I hereby declare that the information provided is true to the best of my knowledge and belief.

INDRAJA M

Timeline

Clinical Data Review

IQVIA
10.2022 - Current

Bachelor of Pharmacy (B.Pharm) -

Al-Ameen College of Pharmacy

12th Science -

Sri Chaithyana PU College

10th -

Nazareth School

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Indraja M