Vibhusha Dangore

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.

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.

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.

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.

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.