Natalie Negron, PMP, CSM
5.0
(1)
Studied at Poole College of Management at North Carolina State University
Works at Ethical Icon
Successful clients at
Not currently taking new clients
Work Experience
Project Manager
Ethical Icon
October 2022 - Present
•Leads a cross functional team (e.g. Clinical Trial Managers, Clinical Data Scientists, Biostatisticians, Medical Directors) on three projects valued at $41 million dollars. •Partnered with senior leadership to build a culture of resilience through targeted training programs and continuous improvement initiatives. •Develops project plans such as communication plans, work break down structure, schedules, vendor and resource management plans. •Strategically prioritizes tasks, delegated responsibilities to team members, and facilitated transparent communication by providing up-to-date project progress through interactive dashboard, executive presentations, face to face meetings and comprehensive monthly reports to clients.
Study Manager
U.S. Food and Drug Administration
April 2021 - October 2022
• Manages a portfolio ranging from 15-18 Clinical Trials both global and local clinical studies with varying complexity; typically utilizing PMP or Agile Practices • Facilitates customer satisfaction through regular given feedback, and building trusted relationships • Drove impressive improvement in the PM department by mentoring, training, and leading a team of 15 newly hired Global Study Managers Public Speaking
Project Assistant to COO
WSP
June 2020 - March 2021
• Managed and Assisted the day-to-day operations of an Expanded Access Program in accordance with domestic and international ICH/GCP, rules, laws and regulations under the supervision of Senior PM • Served as a one of the primary Sponsor contacts for operational project-specific issues and study deliverables • Assisted in the review of site invoices and ensured payments were in accordance to Clinical Study Agreement • Analyzed project quality by identifying risks and reporting to Senior PM for planning of appropriate corrective actions • Mentored and trained 2 new hires onto study team
Site Manager
IQVIA
May 2019 - August 2019
•Formulated a detailed action plan to train assigned staff member on regulatory and organizational protocol, processes and procedures. •Devised plans for hospital leadership to streamline resource management and enhance overall operational efficiency. •Attained and retained patient enrollment numbers by simplifying trial design through educational documents to help patients and hospital staff understand procedures, benefits and risks of study. •Monitored and reviewed study files in accordance with mandated federal laws.
Undergraduate Teaching Assistant
Duke University
August 2018 - August 2019
• Contributed to a Phase I Qualitative Clinical Study for the Department of Maternal and Child Health for women aged 18-49 in Lima, Peru • Programmed, reviewed and edited surveys using Qualtrics Software to find strategies that improved quality and timeliness of patient triage in community-based settings • Facilitated the success of the project by eliminating project walls or gaps within research • Conducted two meta-synthesis literature reviews using EndNote concerning reasons of maternal mortality such as: 1) decision to seek healthcare, 2) transportation to get healthcare and 3) adequate equipment to provide care • Analyzed and ensured the quality of surveys loaded in Qualtrics was concise and accurate information to be distributed • Delivered and assisted in presenting interim reports and findings to Duke Clinical Research Institute
Education
Poole College of Management at North Carolina State University
Master of Business Administration - MBA
2022 - 2025
Public Speaking
University of North Carolina at Chapel Hill
Bachelor's degree, Global Health Studies, Minor Public Policy concentration of Health Policy
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Overall Rating
5.0
Natalie has helped Leland clients get into FTI Consulting