Ezhilarasi Nallathambi
Chennai
Summary
Dynamic project management professional with expertise in Veeva Vault and a strong foundation in ICH-GCP guidelines. At Sanofi Healthcare, I successfully coordinated video projects and ensured high-quality medical materials. Known for effective communication and problem-solving skills, I thrive in collaborative environments, consistently delivering results that enhance operational efficiency.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Associate Project Specialist
Sanofi Healthcare India Pvt. Ltd.
Hyderabad
08.2024 - Current
- Coordinated with content enhancement team, writers, and stakeholders to execute requirements for ADVENT video-based projects
- Created EduRes pages on ADVENT platform, launching content in globally approved countries post-approval
- Uploaded educational resource pages onto Veeva PromoMats for review and approval
- Facilitated localization of materials when product references were present
- Managed quality control activities to ensure high standards for various medical materials, including posters, slide decks, manuscripts, newsletters, infographics
TMF Specialist
ICON Clinical Research India (P) Ltd
Chennai
11.2020 - 07.2024
- Managed electronic document management processes utilizing Veeva Vault eTMF platform across various clients.
- Oversaw Trial Master File activities, including document review and processing to ensure Inspection readiness.
- Conducted Quality Control reviews of eTMF documents for compliance with GCP standard operating procedures.
- Collaborated with Document Specialists and local CRAs to rectify incomplete or incorrect documentation.
- Tracked action items within CTMS according to client requirements.
- Performed reconciliation to maintain data accuracy.
- Mentored and trained new team members on eTMF processes and best practices.
- Monitored TMFs for trends, quality, and completeness to enhance operational efficiency.
Project Management Associate
Azidus Laboratories Ltd.
Chennai
12.2017 - 02.2020
- Managed projects efficiently, ensuring timely delivery while adhering to SOP and regulatory guidelines
- Traveled overseas to attend stakeholder meetings.
- Delivered project kick-off presentations to establish clear objectives and timelines
- Prepared contracts, statements of work, and invoices for project initiation and financial tracking
- Secured necessary resources for clinical projects by sourcing from top vendors
- Developed and monitored study timelines and deliverables to ensure compliance
- Created and managed meeting agendas and minutes for effective communication
- Conducted literature searches, prepared, and published research articles of the study conducted at the site
- Uploaded the final study documents to the eTMF as part of CTMS, and performed QC checks of the study documents
Education
MTech - Biomedical Engineering
VIT University
Vellore, India08-2016
High School Diploma -
SunBeam School
Vellore, India05-2010
Skills
- Veeva Vault Clinical and PromoMats
- pTMF and CTMS systems
- Microsoft Office proficiency
- Project management
- Problem solving
- Effective communication
- Presentation skills
- Team collaboration
- ICH-GCP E6 guidelines knowledge
- Clinical study regulations expertise
Certification
- ICH-GCP workshop on clinical research
- Basic Life Support (BLS)
- FDA and MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials
Disclaimer
I hereby declare that all the information above is true to best of my knowledge. I assure that I will put my best efforts, if given an opportunity.
Publications
A Full Replicate in vivo Bioequivalence Study of Two Idelalisib 150 mg Tablets in Fasted Healthy Adult Human Subjects, Journal of Bioequivalence and Bioavailability
Languages
Tamil
First Language
English
Advanced (C1)
C1
Timeline
Associate Project Specialist
Sanofi Healthcare India Pvt. Ltd.
08.2024 - Current
TMF Specialist
ICON Clinical Research India (P) Ltd
11.2020 - 07.2024
Project Management Associate
Azidus Laboratories Ltd.
12.2017 - 02.2020
MTech - Biomedical Engineering
VIT University
High School Diploma -
SunBeam School
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