Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narratives, clinical study reports (CSR), responses to regulatory health authorities. Experienced in adverse events adjudication, study endpoint and closely monitored event reporting including independent safety committee evaluation, SAE reconciliation, data validation, QC of periodic safety reports and CSRs for GCP and ICH compliance including CFR part 11, Trial Master File (TMF) subject matter expert, expertise in project management of regulatory submissions from IND thru WMA. I have experience with both early and late stage clinical trials covering Phase I, II and Phase III long-term international, multi-site trials in oncology, vaccines, neurology, diabetes, infectious disease and asthma. As a quality assurance auditor at both Merck and Charles River Laboratories I was responsible for audit/quality review of report submissions of INDs, IND amendments, NDAs, CTDs, WMAs submitted to FDA, EU, MHRA and other worldwide health authorities. My scientific clinical and preclinical experience, regulatory compliance training coupled with my years of experience in project management of accelerated compounds to man provides a broad knowledge of requirements for the complete drug development process from IND thru WMA.

Highlights:

• Protocol
• Oncology
• Audit
• Monitoring
• Critical Care - Neurology
• ICH
• Neurology
• Quality Assurance
• Test
• Data Quality