ASHWINI MEHTA
CHALISGAON
Summary
Results-driven Senior Clinical Publishing Coordinator with over three years of experience in clinical publishing and pharmaceutical operations. Expertise in managing the complete publishing process while ensuring compliance with regulatory standards. Demonstrated proficiency in Clinical Trial Management Systems, enhancing efficiency and quality in documentation delivery. Strong attention to detail contributes to successful project outcomes and continuous improvement initiatives.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Senior Clinical Publishing Coordinator
Labcorp
06.2021 - Current
- Efficiently managed setup operations of clinical trials, ensuring compliance with protocols and regulatory standards.
- Drafted and maintained Clinical Investigator Manuals, requisitions, and essential documentation per the Statement of Work.
- Collaborated with GSMs, SDLs, and clients to address specific needs for timely project completion.
- Day-to-Day Initiative Management.
- Oversaw daily tasks and initiatives, ensuring timely client submissions, and high-quality deliverables.
- Coordinated with internal teams for accurate and timely desktop publishing documentation.
- Ensured compliance and timely submission of deliverables for client evaluations with utmost quality.
- Enhanced cross-departmental efficiency by coordinating with internal teams for project support.
- • Quality Documentation and Compliance.
- Maintained high standards in preparing Clinical Investigator Manuals and Requisitions for various projects.
- Regularly reviewed and revised clinical documents to ensure accuracy and relevance with updated project requirements and regulatory guidelines.
- Ensured all documentation was completed within designated timeframes with compliance requirements met.
- • Achievement.
- Successfully coordinated clinical trial documentation, enhancing project efficiency and client satisfaction.
Education
BSC Biotechnology -
HPT ARTS And RYK Science College
Maharashtra05-2019
Intermediate -
R.V. Junior College
Maharashtra05-2016
Secondary School Certificate -
A.B. Girls High School
Maharashtra05-2014
Skills
- Clinical Publishing
- Regulatory compliance
- Clinical Trial Management Systems (CTMS)
- ICH-GCP Guidelines
- FDA regulations
- Document Management
- Data accuracy
- Project Management
- Workflow Optimization
- Cross-Functional Collaboration
- Quality Assurance
- Data analysis
- Publishing software
- Risk Management
- Attention to detail
- Time management
- Communication Skills
- Technical documentation
- Problem solving
Languages
- Hindi, Native
- English, Proficient
- Marathi, Advanced
Accomplishments
- Received Various " ACE Awards for CLIENT EXCELLENCE, PROCESS EXCELLENCE and PEOPLE EXCELLENCE.
Certification
- Advanced Post Graduate Program in Clinical Research and Management.
Declaration
I hereby declare that all the information given above is true and correct to the best of my knowledge and I take full responsibility for its accuracy and authenticity.
Best Regards,
Ashwini Mehta
Timeline
Senior Clinical Publishing Coordinator
Labcorp
06.2021 - Current
BSC Biotechnology -
HPT ARTS And RYK Science College
Intermediate -
R.V. Junior College
Secondary School Certificate -
A.B. Girls High School
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