Ezhilarasi Nallathambi
Hyderabad
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
2
2
Languages
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 Educational Resource pages on ADVENT platform, launching content in globally approved countries post-approval
- Enhanced the ADVENT process through process optimization and collaborated on the development of detailed process maps
- Uploaded educational resource pages onto Veeva PromoMats for review and approval
- Facilitated localization of materials when product references were present
- Managed a pilot initiative for translating medical videos into various languages and developed a standardized protocol to streamline execution and ensure compliance
- Managed quality control activities to ensure high standards for various medical materials, including posters, slide decks, manuscripts, newsletters, and 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
08.2016
High School Diploma - undefined
SunBeam School
05.2010
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
Languages
Tamil
Bilingual or Proficient (C2)
English
Advanced (C1)
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.
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 - undefined
SunBeam School