Dr. Swatismita Dhar

• handling seven projects for Germany, supporting the Regional Managers, CRAs and SSU CRAs • trial document submission for approval in ethical committees and other competent authorities (Interventional and non-Interventional studies) • planning for site initiation, Investigator site Folders, preparation of Patient starter package, management of site documents and their quality check, site closure and data reconciliation • TMF data upload and QC management for inspection readiness and audit

•Project Management- national and international network scientific projects Group leader, Laboratory management, data analysis, ensuring Good Laboratory Practice (GLP), quality assurance •Strategic planning for development of biopharmaceutical products - an edible anti-cancer therapeutic and dietary supplements - scientific discussions with experts, sponsors and end users survey, business plan, solving complex regulatory issues and market access

• Research in the field of „Rice Functional Genomics“ • Writing projects, project reports, planning their implementation and publication • Laboratory management for GLP and cooperation with team researchers

Clinical trial-Phase I-IV, ICH-GCP, EU-Richtlinie, AMG, MPG, agencies, audits Regulatory affairs (AMG, MPG), Pharmaceutical law and regulatory environment, GxP Project Management , PM models, bar charts (GANTT), network plans, SWOT analysis, MS Project

Qualified TELC B2 certficate

• Transcriptome analysis with microarray of rice in reproductive developmental stages, abiotic stress conditions, identification and cloning of candidate genes and functional characterization by development of transgenic rice