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GiseleMalvezzi/README.md

Gisele Malvezzi

Profile Views

About me

Biomedical scientist and data-driven clinical research professional with expertise in healthcare analytics, study management, and AI applications in medicine. Currently advancing specialization in Statistics for Data Science at PUC Minas, with postgraduate credentials in Data Science and Big Data.

Core Expertise:

  • Clinical data analytics and quality assurance in multi-site research environments
  • Healthcare BI development and statistical modeling (Power BI, R, SQL, Python)
  • AI-driven solutions for clinical decision support and operational efficiency
  • Protocol leadership in vaccine trials, oncology, and critical care studies

International Impact: Collaborated on global clinical trials with diverse stakeholders, ensuring data integrity and regulatory compliance across multiple therapeutic areas.

Thought Leadership: Creator of educational content on clinical research career transitions, bridging the gap between biomedical sciences and data-driven healthcare innovation.

Experiences

Clinical Data Management & Analytics

  • Led data quality and integrity operations for international clinical trials, implementing robust validation protocols that reduced data discrepancies by ensuring compliance with GCP/ICH guidelines
  • Designed and deployed interactive dashboards (Power BI, Excel) and automated reporting systems for real-time study monitoring and decision support
  • Developed advanced SQL queries and R-based statistical analyses for clinical endpoints and safety surveillance

Study Leadership & Project Management

  • COVID-19 Vaccine Study Lead: Directed site operations for Janssen COVID-19 vaccine trial, managing patient recruitment, protocol adherence, and regulatory submissions under accelerated timelines
  • Coordinated multicenter protocols across oncology, ICU, and medical device studies, ensuring seamless execution and stakeholder alignment
  • Managed clinical project budgets, timelines, and deliverables for high-stakes pharmaceutical and biotech partnerships

Innovation & Education

  • Pioneered AI and technology integration in healthcare workflows, exploring machine learning applications for predictive analytics and patient outcomes
  • Developed and delivered "Career Transition to Clinical Research" training module, empowering biomedical professionals to enter the clinical research field
  • Created comprehensive CRFs (Case Report Forms) optimized for data capture efficiency and downstream analytics

Technologies

Power BI • SQL • R • Python • Excel (VBA) • REDCap • Javascript • Git

Education

  • Specialization in Statistics for Data Science - PUC Minas (ongoing)
  • Postgraduate in Data Science and Big Data - PUC Minas
  • Biomedical Sciences - UNINOVE

Contact

LinkedIn Email WhatsApp YouTube

Pinned Loading

  1. clinical-data-cleaning-pipeline clinical-data-cleaning-pipeline Public

    Automated pipeline for clinical data cleaning and validation in R

    R 2

  2. clinical-google-sheets-automation clinical-google-sheets-automation Public

    Clinical report automation using Google Sheets and Apps Script

    JavaScript 2

  3. GiseleMalvezzi GiseleMalvezzi Public

    Special profile configuration