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Dawn Niccum

Sr Director, Quality Assurance & Compliance, inSeption Group

Dawn Niccum

Sr Director, Quality Assurance & Compliance, inSeption Group

Biography

As inSeption’s Head of Quality Assurance, Dawn is responsible for all areas of QA including compliance, policies/SOPs, training, and eTMF.  She is recognized for her expertise in the development, maintenance, and remediation of TMFs including metrics and QC checks. She is a Subject Matter Expert and member of the TMF Reference Model Group and an Ambassador of the Metrics Champion Consortium (MCC) where she helped build a standardized set of TMF metrics.  She has presented at numerous conferences on the importance of TMF inspection readiness. Dawn holds a Master’s Degree in Regulatory Affairs and Quality Compliance, certifications as a Clinical Research Associate (CCRA), Registered Quality Assurance Professional – GCP (RQAP-GCP), Project Manager (PMP), and is a registered nurse. 

All sessions by Dawn Niccum