Summary: Over 16 years managing clinical trials and data collection activities. Manage as Point of contact for sponsors, project teams, and investigational sites to facilitate clinical studies Phase I-IV. Responsible for the review and approval of case report forms, electronic data capture systems, review of protocols, implementing study procedure manuals, and monitoring plans. Additionally manage site selection, study execution, including oversight of CRO, monitoring activities, study conduct, clinical trial serum sample tracking (safety and immunogenicity), compliance with regulatory standards, and completion of data transfer. Experienced in conducting, managing and supervising clinical quality assurance audits of internal systems, investigational sites, and sub-tier vendors. Prepared audit reports and ensured corrective actions that were identified in these reports were satisfactorily addressed according to ICH guidelines (E6). Assisted in the development of standard operating procedures for the Clinical Operations and Clinical Quality Assurance and provided GCP training, Scientific Misconduct Awareness, and Lessons Learned presentations.

Highlights:

• Collection
• Quality Assurance
• Test
• Process Improvement
• Project Management
• Project Manager
• Business Requirements
• Clinical Research
• Data Entry
• Filing