Rukma Pawar
ETMF Editor
Bengaluru
Summary
Disciplined and insightful eTMF quality reviewer with 2.8 years of experience working in Accenture Private limited solutions. Determined team player with experience in identifying and tracking key issues.
Overview
3
3
years of professional experience
5
5
years of post-secondary education
1
1
Certification
Work History
ETMF Quality Reviewer
Accenture India Private Limited
Bengaluru
08.2020 - Current
- Quality Review of electronic documents residing in the
electronic Trial Master File (eTMF) system. - Worked in pilot eTMF DM project to make sure the Data management related documents are residing in veeva vault for inspection readiness.
- Upload documents to eTMF as needed.
- Ability to make decisions based on evidence (guidance and reference documents, SharePoint Team site and Manual of Operations) and experience regarding the outcome of the quality review of critical or complex documents.
- Maintain eTMF Database in support of client and Perform Self Evident Corrections for issues specified by clients.
- Perform quality validation of quality reviewed documents, as needed.
- Assist in training, mentoring of new hires and ongoing process changes, if required.
- Other task- Engaged in assisting the daily task to team members and make sure every task is completed at given point of time.
Education
Master of Science - Biotechnology
06.2017 - 07.2019
Bachelor of Science - PCMB
06.2012 - 07.2015
Skills
Veeva vault software proficiency
Thorough knowledge of GCP and FDA Principles and regulation
Active Listener and Fast learner
Self Motivator
Business communication
Time management and stress management
Honesty
Certification
Industry skill Enhancement professional Certificate in Clinical Research
Timeline
ETMF Quality Reviewer - Accenture India Private Limited
08.2020 - Current
Industry skill Enhancement professional Certificate in Clinical Research
03-2020
Akkamahadevi Karanataka State Women's University - Master of Science, Biotechnology
06.2017 - 07.2019
S.B Arts And K.C.P Science College - Bachelor of Science, PCMB
06.2012 - 07.2015