Cross Trainings
Akhil Nagadasari
TMF Document Specialist
Bengaluru
Summary
Proactive TMF Document Specialist at IQVIA with expertise in EDL management and quality review. Recognized for mentoring new hires and enhancing document accuracy, I excel in stakeholder collaboration and process improvement, ensuring compliance with ICH and GCP guidelines while maintaining high-quality standards in clinical trial documentation.
Overview
3
3
Languages
3
3
years of professional experience
Work History
TMF Document Specialist
IQVIA
12.2022 - Current
- Uploaded, indexed, and conducted quality review and quality control of clinical trial documents in eTMF system using Veeva Vault platform for all assigned studies, ensuring completeness and accuracy of documentation
- Managed daily document allocation for the entire team and served as the Point of Contact (POC) for TMF document management in Bulgaria and South Africa.
- Responsible for daily documents allocation for entire team and Point of Contact (POC) for document management and POC for Bulgarian and South african country for all TMF document management
- Recognized as a dependable team member with a proactive approach to resolving filing/QC related issues and maintaining quality standards
- Mentored new hires on uploading and quality review processes for two consecutive quarters, facilitating smoother onboarding and knowledge transfer
Education
Master of Science - Pharmaceutical Sciences
Andhra University
Visakhapatnam, India 04.2001 -
Bachelor of Science - Pharmaceutical Sciences
Acharya Nagarjuna Univeristy
Guntur, India 04.2001 -
Skills
Critical Thinking & Problem-solving
Teamwork and Multi-tasking
Expected Document List (EDL) Management
TMF Periodic / File Review
Regulatory Compliance
ALCOA
Stakeholder Collaboration
Process Improvement
Knowledge on Ethical issues & guidelines (ICH, GCP, IEC/IRB)
Interests
Technical Skills
- Veeva Vault
- Wingspan
- IeTMF
- CTMS (IL2)
- Medidata Rave
- MS PowerPoint, MS Word
- Excel
Timeline
TMF Document Specialist
IQVIA
12.2022 - Current
Master of Science - Pharmaceutical Sciences
Andhra University
04.2001 -
Bachelor of Science - Pharmaceutical Sciences
Acharya Nagarjuna Univeristy
04.2001 -