NAGASHREE RAHUL RAO
Bangalore,Karnataka
Summary
A seasoned professional with over eight years experience in the field of Clinical Research. Clinical research experience include Inspection Readiness, TMF maintenance, Medical Imaging quality. On the personal front, my love for gardening is an addiction. I practice composting and conduct workshops on composting during free time
Overview
18
18
years of professional experience
Work History
Senior TMF Specialist
Fortrea
Bengaluru
01.2025 - Current
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
- Followed all company policies and procedures to deliver quality work.
- Championed the adoption of new software tools that streamlined workflows across multiple departments.
- Perform quality control checks on TMF documents to ensure they are accurate, complete, and properly filed.
- Verify documents against the TMF Index / Reference Model, such as the model maintained by the TMF Reference Model Initiative.
- Ensure documents are correctly named, dated, version controlled, and filed in the appropriate TMF artifact location.
- Identify missing, incomplete, or incorrectly filed documents and raise queries for correction.
- Ensure compliance with Good Clinical Practice (GCP) and applicable regulatory requirements.
- Track and follow up on TMF QC findings and resolution.
- Support TMF health checks and completeness reviews.
- Assist in preparing TMF for internal audits and regulatory inspections.
- Work closely with Clinical Operations, Study Teams, and Document Management teams to resolve QC issues.
- Maintain QC logs, trackers, and metrics.
- Process trainer
Etmf Specialist
Fortrea
08.2021 - Current
- IPerform quality review of Trial Master File (TMF) documents for completeness, accuracy, and compliance.
- Ensure documents are filed in the correct TMF sections using the appropriate TMF Reference Model.
- Identify missing, incomplete, or incorrect documents and follow up with study teams.
- Maintain inspection readiness of TMF throughout the study lifecycle.
- Perform periodic TMF health checks and completeness reviews.
- Support internal and external audits or regulatory inspections.
- Track and resolve TMF quality issues and document discrepancies.
- Collaborate with Clinical Operations, Regulatory, and Study Management teams.
- Maintain proper documentation in electronic TMF systems (eTMF).
- Generate TMF review reports and metrics.
Data Analyst
Cognizant Technologies Pvt Ltd
10.2019 - 08.2021
- Central Filing Manager (eTMF)
- Prefiling, Post filing and quality review of Trial level documents
- Upload and create cover sheets for Trial level documents
Medical Image Reviewer
Cognizant Technologies Pvt Ltd
02.2019 - 09.2019
- Reviewing medical images and masking patient information
- Prepare training material and maintain query log.
- Create workflow through Zendesk ticketing system
- Mentor new joiners and shadow their work
Student Mentor
BASE educational Services Pvt Ltd
10.2018 - 02.2019
- Monitoring students' progress academically.
- Implementing confidence building activities
- Arrange special classes and one to one coaching
- Discuss students progress with parents
- Inform students about career fields/ disciplinary areas
Teacher
Pakistan Islamia higher Secondary School, Ajman, UAE
02.2011 - 04.2012
- Science teacher for Grades 6, 8 and 10
- English speaking teacher for Grades LKG to 10
- Computer teacher for Grades 5 and 6
Inspection Readiness Associate
Accenture Services Pvt Ltd
05.2008 - 04.2010
- Review study documents to ensure compliance with ICH-GCP, client SOP's
- Identify and evaluate potential discrepancies in the documents to facilitate FDA, MHRA inspections
- Quality check of all documents from Site Qualification Visit upto Site Close Out Visit
Process Executive
Accenture Services Pvt Ltd
12.2007 - 04.2008
- Clinical Study Report Appendices Associate
- Review Clinical Study documents electronically and build appendices
- Enter and verify data using information stored electronically
Education
Bachelor of Education -
Cauvery B.Ed College
Bengaluru01-2021
Bachelor of Science -
Maharani's College For Women
Bengaluru01-2007
Master of Science - Microbiology
St Joseph's College of Arts And Science
Bengaluru01-2005
Skills
- Clinical Research
- Veeva Vault
- ICH GCP
- Quality Control
- Soft Skills trainer
- Analytical thinking
Interests
Gardening, Composting, Travelling
Timeline
Senior TMF Specialist
Fortrea
01.2025 - Current
Etmf Specialist
Fortrea
08.2021 - Current
Data Analyst
Cognizant Technologies Pvt Ltd
10.2019 - 08.2021
Medical Image Reviewer
Cognizant Technologies Pvt Ltd
02.2019 - 09.2019
Student Mentor
BASE educational Services Pvt Ltd
10.2018 - 02.2019
Teacher
Pakistan Islamia higher Secondary School, Ajman, UAE
02.2011 - 04.2012
Inspection Readiness Associate
Accenture Services Pvt Ltd
05.2008 - 04.2010
Process Executive
Accenture Services Pvt Ltd
12.2007 - 04.2008
Bachelor of Education -
Cauvery B.Ed College
Bachelor of Science -
Maharani's College For Women
Master of Science - Microbiology
St Joseph's College of Arts And Science
Composting, gardening
- Home gardening and plant care
- Composting and sustainable waste management
- Growing organic vegetables and herbs