Saptaparni Das

WORK HISTORY

EDUCATION

SKILLS

ABOUT SAPTAPARNI DAS

Based in Toronto, Canada• Clinical Data Manager with END to END experience in the areas of Clinical Sciences, Clinical Data Management, Clinical Trials, Research and Data Analysis.• 11+ years of extensive experience collaborating with a diverse range of Sponsors in Contract Research Organization (CRO), Pharmaceutical, and Healthcare industries demonstrating business and analytical acumen.• Recognized for exceptional performance, receiving the Award of Excellence for identifying critical discrepancies crucial for FDA drug approval.• Proven track record in Project Management, successfully leading multiple projects concurrently while maintaining strong client relationships.• Through experience in SAE Reconciliation and Vendor Data Reconciliation.• Excelled in Data Visualization, adept at developing insightful visualizations using BI tools like MS Power BI and Tableau. Developed and implemented data visualization solutions resulting in 22% improvement in decision-making processes• Strong knowledge of ICH-GCP, TCPS2, Health Canada and FDA regulations.• Championed in the Electronic Trial Master File (eTMF) management, QC, and Note to File.• Instrumental in driving efficiency and quality improvements, contributing to a 70% reduction in data errors as part of a data quality improvement team.• M.Sc in Biotechnology, a PG Diploma in Clinical Data Management, and certifications such as Barnett GCP Accreditation and Microsoft Power BI Desktop for Business Intelligence.• Strong team collaboration skills in an Agile environment and experience in using tools such as JIRA, Confluence and Asana. Created automated monthly dashboards with Power BI, saving 5 hours per week Streamlined data collection process, saving 8 hours per weekCore competencies:• Languages: Python• Database Platforms: SQL, MySQL, PostgreSQL• Big Data Technologies: Apache Hadoop, Apache Spark• Data Visualization: Tableau, MS Power BI (DAX), Pandas (Matplotlib, Seaborn)• Operating Systems: Windows, Linux• Project Management and Collaboration Tools: JIRA, Confluence, Smartsheet• Project Methodologies: Agile• Clinical Databases CDMS: Data Labs, Medidata Rave, Inform, Oracle Clinical, OCRDC, CTMS-ICOTrial, e-TMF, p-TMF, Veeva Vault, ICOMaster• Clinical Phases experience: Phase I, Phase and Phase II• Therapeutic Area experience: Neurology, Rheumatology, Endocrinology, Oncology, Gastrointestinal and DermatologyConnect with me on LinkedIn or reach out via email at s••••••••@gmail.com to explore potential collaborations.