Lisa N.
Drive Innovation and Ensure Data Integrity in Oncology, Neuroscience, Cardiovascular, and Infectious Diseases Research for Biomedical Industries
- Role
- Clinical Data Manager at Magnus
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Lisa N.
I am a highly experienced senior clinical data manager and epidemiologist with a comprehensive background in healthcare and clinical research across biomedical industries, such as pharmaceuticals, biotechnology, and medical devices. I am dedicated to advancing public health and facilitating significant medical breakthroughs.My work is delivering high quality, regulatory compliant data that supports clinical decision making, regulatory submissions, drive advancements in medical innovation, and ultimately enhances patient outcome.I bring substantial expertise in FDA 510(k) and premarket approval (PMA) submissions, investigational device exemption (IDE) strategies, along with a successful history of preparing for and navigating bioresearch monitoring (BIMO) inspections.I am proficient in advanced data analytics, including statistical analysis, modeling, visualization, and reporting through SAS, R, SQL, and clinical data Management systems (CDMS). I have demonstrated proficiency in applying the following key international guidelines and regulations- 21 CFR Part 11 - Clinical Data Interchange Standards Consortium (CDISC)- Clinical Data Acquisition Standards Harmonization (CDASH)- General Data Protection Regulation (GDPR)- Good Clinical Data Management Practice (GCDMP©)- Good Clinical Practice (GCP)- Health Insurance Portability and Accountability Act (HIPAA)- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines - Medical Dictionary for Regulatory Activities (MedDRA)
Experience
Clinical Data Manager
Apr 2025 — Present · CA, US
Education
University of Minnesota School of Public Health
Master of Public Health, Epidemiology and Biostatistics
University of Minnesota College of Biological Sciences
Bachelor of Science, Neuroscience and Public Health
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