Harita Veereshlingam
Staff Scientist, Clinical @Thermo Fisher Scientific
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WORK HISTORY
Staff Scientist, Clinical @Thermo Fisher Scientific
South San Francisco, CA, US
Led Strategy, Design and Execution of several successful Clinical Validation studies for EUA, 510K and IVDR submissions. • Determined Clinical Study strategy for in-vitro diagnostic devices for 510K and CE-IVDR Submissions. • Led scientific content of clinical project deliverables including scientific design of studies, study plans, protocols and reports.• Designed proficiency studies, trained external collaborators on investigational technology, clinical study design and ensured successful execution of clinical trials in collaboration with Clinical Affairs.• Designed and executed pre-clinical studies, data analyses, interpretation and clinical design strategies.• Authored Clinical Investigations sections in Premarket Approval Applications, Instructions for Use (IFU) and Clinical Performance testing section in 510(k) submissions. • Led several clinical projects requiring coordination with internal and external cross functional teams.• Led Process improvement to achieve higher (a) efficiency and (b) cost savings for IVD product development.• Collaborated with Medical Affairs in generating high value scientific publications towards product marketing efforts.
EDUCATION
University of North Texas
Doctor of Philosophy (Ph.D.), Molecular Biology
University of Mumbai
Master of Science (M.Sc.), Microbiology and Biotechnology
SKILLS
ABOUT HARITA VEERESHLINGAM
Results-driven Scientist with extensive experience in in vitro diagnostic clinical development, specializing in clinical studies for IVDR and 510(k) submissions. Strong background in designing and executing on analytical and clinical validation studies, statistical data analysis and project management. Excellent interpersonal and communication skills enabling collaborations with internal and external cross-functional teams to achieve regulatory as well as commercial objectives.
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