Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Timeline
Generic

Pooja R

Bangalore

Summary

Dynamic Data Operations Coordinator with expertise in managing clinical trial data across Phase 1 to 4 studies and leading teams to project success. Skilled in data review, resolution, and quality control, ensuring high standards of accuracy and compliance. Proficient in data review, resolution, and quality control, with strong communication skills for collaborating with internal teams, vendors, clients, and stakeholders.

Overview

4
4
years of professional experience

Work History

Clinical Data Specialist

IQVIA RDS Pvt Ltd
Bangalore
09.2021 - Current
  • Data Operations Coordinator (DOC) for different protocol as assigned by the team and manage 5 to 8 team members depending on study need across Phase 1 to 4 of clinical trials.
  • Manage delivery of projects through full clinical data management (CDM) study life-cycle of Start-up/Conduct/Close out (with minimal guidance).
  • Conducted comprehensive data management tasks including review, clarification, and resolution, maintaining data integrity throughout.
  • Collaborated with external vendors for data integration setup, validation, and cleaning processes.
  • Negotiated timelines and responsibilities with CDM team members, ensuring efficient project execution.
  • Conducted user acceptance testing (UAT) and performed quality control procedures to validate data accuracy and compliance.
  • Developed and reviewed data management plans, validation procedures, and data entry processes
  • Increased productivity and efficiency by regularly reevaluating processes and technologies.
  • Maintained electronic Trial Master File (eTMF) documentation and communicated effectively with clients and stakeholders.
  • Provided guidance and mentorship to junior team members.

Drug Safety Associate Trainee

IQVIA,RDS Pvt Ltd
Bangalore
11.2020 - 09.2021
  • Manage cases from both spontaneous and solicited sources, ensuring adherence to regulatory requirements and company guidelines.
  • Conduct thorough quality reviews of cases to maintain data accuracy and integrity.
  • Close cases within stipulated timelines to meet reporting requirements and regulatory deadlines.
  • Write comprehensive case narratives based on case category, providing detailed descriptions of adverse events and associated factors.
  • Develop and deliver training programs to new hires, facilitating their understanding of case handling processes and ensuring compliance with company standards.

Education

Master of Science - Biotechnology

Mount Carmel College (Autonomous)
Bangalore
11-2020

Skills

  • CDM Tools and System (Rave , Inform, Veeva )
  • Data Cleaning
  • Data Reconciliation (Vendor and SAE)
  • Validate Clinical Trial Data
  • User Acceptance Testing
  • Coordinate with cross functional teams
  • Microsoft Office
  • Interpersonal Communication

Accomplishments

    Successfully delivered final and interim database locks with 100% quality as a new Data Operations Coordinator. Completed three study final database locks within tight deadlines, earning Impact Awards from Data Team Leads and Management for timely delivery.

Languages

French
First Language
English
Proficient (C2)
C2
Hindi
Intermediate (B1)
B1
Malayalam
Intermediate (B1)
B1

Timeline

Clinical Data Specialist

IQVIA RDS Pvt Ltd
09.2021 - Current

Drug Safety Associate Trainee

IQVIA,RDS Pvt Ltd
11.2020 - 09.2021

Master of Science - Biotechnology

Mount Carmel College (Autonomous)

Similar Profiles

CREATE PROFILE
Pooja R