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.