Dawn Niccum

About Dawn Niccum

With over 25 years of Clinical Operations and Quality Assurance pharmaceutical experience, Dawn provides clients a unique perspective of efficiency, speed, and compliance. She is an experienced leader in clinical quality and compliance, SOP development, computer system validation, quality document management, training, and safety. Her extensive experience and strength in establishing quality structures and streamlined approaches to reduce risk remains a tremendous asset in her ability to deliver outstanding quality, best practices, efficient systems, and cost savings to clients.Specialties: TMF, Clinical Quality Assurannce & Auditing, Quality Systems, CTMS, Document Management, Training, Project Management, Regulatory and Quality Compliance, Risk Management and Clinical Trial Oversight

Experience

1. Executive Vice President, Quality Assurance

   Inseption Group

   Feb 2023 — Present · Audubon, PA, US

Education

• Purdue University

  BS, Nursing

  1984 — 1988

• Purdue University

  Masters Degree, Regulatory Affairs and Quality Compliance

  2006 — 2009

• Western Governors University

  Master of Science - MS, Nursing Education

  2021 — 2022

Skills

• Ich-Gcp
• Clinical Development
• Clinical Research
• Compliance
• Clinical Trials
• Oracle Clinical
• Ilt
• Netmeeting
• Portals
• Webex
• Electronic Data Capture (Edc)
• Standard Operating Procedure (Sop)
• Snagit
• Negotiation
• Drug Development
• Gcp
• Hands-on Training
• Web Design
• Live Meeting
• CRO Management
• Oncology
• Infectious Diseases
• Visio
• Project Management
• Training &Amp; Development
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Good Clinical Practice (Gcp)
• Budget Negotiation
• Training
• Pharmaceutical Industry
• Sop
• Fda
• CRO
• U.s. Food and Drug Administration (Fda)
• Ms Project
• Instructional Design
• Edc
• Therapeutic Areas
• Ctms