Vibhusha Dangore
@vibhushadangore
Experienced Clinical Trial Professional and eTMF Specialist.
IndiaWhat I'm looking for
I am a Clinical Trial Professional and eTMF Specialist with over 8 years of experience in clinical research and trial documentation. My expertise lies in managing global clinical studies, ensuring regulatory compliance, and overseeing eTMF systems such as Veeva Vault. I excel in cross-functional coordination and sponsor communication, driving inspection-readiness across all phases of clinical trials.
Throughout my career, I have successfully managed multiple global clinical trial sites, ensuring 100% compliance with ICH-GCP and sponsor protocols. My dedication to quality and accuracy has been recognized through various awards, including 'Star of the Month' at Tata Consultancy Services and accolades for excellence in eTMF management. I am passionate about mentoring and enhancing team knowledge, contributing to the overall success of clinical operations.
Experience
Work history, roles, and key accomplishments
Senior Process Associate- eTMF Management
Tata Consultancy Services
Feb 2022 - Present (3 years 6 months)
Oversaw planning, structuring, filing, indexing, and archiving of eTMF documentation throughout study phases, ensuring 100% compliance with SOPs and GCP for multiple global trials. Managed Essential Document Lists (EDLs), monitored TMF health metrics, and performed QC reviews to ensure inspection readiness.
Associate- Clinical Operations
Excel Life Sciences Private Limited
Apr 2018 - Present (7 years 4 months)
Coordinated the preparation and submission of regulatory documents, recruited and screened study participants, and obtained informed consent. Collected, recorded, and managed clinical data, ensuring accurate and timely entry in CRFs or EDC systems while adhering to GCP guidelines.
Clinical Research Coordinator
Amclin Life Sciences Private Limited
Mar 2017 - Present (8 years 5 months)
Managed study preparation and site initiation, including participant recruitment and consent processes. Oversaw study conduct, data collection, and ensured regulatory and compliance adherence, including safety and adverse event reporting.
Education
Degrees, certifications, and relevant coursework
Mitcon Biopharma Centre
Post-Graduation Diploma, Clinical Research, Clinical Data Management and Pharmacovigilance
2016 - 2017
Grade: O (>= 80%)
Completed a Post-Graduation Diploma in Clinical Research, Clinical Data Management, and Pharmacovigilance. This program was offered by Mitcon Biopharma Centre, an institution under the Department of Science & Technology, Government of India.
Rashtrasant Tukadoji Maharaj Nagpur University
B. Tech, Biotechnology
2012 - 2016
Grade: Distinction, CGPA=8.27
Earned a B. Tech degree in Biotechnology from Rashtrasant Tukadoji Maharaj Nagpur University. Graduated with Distinction, achieving a CGPA of 8.27.
Availability
Location
IndiaAuthorized to work in
Job categories
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