Clare Ongera

About Clare Ongera

Ms. Clare Ongera stands out as a dynamic and accomplished professional, showcasing a proven history of executive leadership and strategic guidance. As a seasoned Program Management Professional, her focus lies in delivering value through highly effective and efficient project management practices.Currently contributing to the FDA, Ms. Ongera boasts a rich background in the pharmaceutical industry, with prior roles at Johnson & Johnson and the CDC Foundation. Her impactful work at the CDC Foundation involved efforts to curb the spread of COVID-19.Before her CDC Foundation tenure, Ms. Ongera served as a Biomedical researcher at Infinity Biologix (formerly RUCDR) and as a Clinical Research Associate at RWJMS and Emory University. Her expertise encompassed coordinating operations, managing sites, and crafting detailed clinical reports, all while demonstrating a profound understanding of ICH/GCP guidelines and utilizing document management applications like CTMS and EDC.With a knack for assimilating new ideas and strategies, Ms. Ongera excels in solving complex problems. Analytical thinking, compliance, and process improvement resolutions are among her strengths, complemented by robust management, planning, and organizational skills—essential in navigating dynamic environments with competing projects and deadlines.Her academic journey includes a graduate degree from Rutgers University Graduate School of Biomedical Sciences, where she contributed as a researcher at the Laboratory for Regenerative Neurobiology at the Cancer Research Center. Previous roles at Rutgers School of Health Professions and an undergraduate degree in Biology from Rutgers New Brunswick NJ further showcase her dedication to continuous learning.Ms. Ongera is an active member of the lifelong alumnae network of Rutgers Douglass Residential College. Her skill set spans Pharmaceuticals, Good Clinical Practice (GCP), Biotechnology, Regulatory requirements, and familiarity with global health authorities, including the U.S. Food and Drug Administration (FDA), European Medicines Agency, and Health Canada.

Experience

1. Senior Program Manager

   FDA

   Jan 2025 — Present

Education

• Harvard University

  Master of Business Administration - MBA, Business and Personal/Financial Services Marketing Operations

• Duke University

  ORAQ - Regulatory Affairs Training Program

• Rutgers University

  Biomedical Sciences, Biology/Biological Sciences, General