Cheryl Monroe Email & Phone Number

Responsible for monthly ETL, source data updates, and program improvements to vital data pool used for outpatient reporting. Create robust outpatient trend report for multiple lines of business with flexible drill-down capabilities. Extract, aggregate and perform quality assurance on applicable data from multiple sources and tables for purposes of root cause analysis, affordability initiative development, and validation and measurement of medical expense reduction initiatives. Perform statistical analyses. Develop conclusions and recommendations. Communicate results to relevant audiences. Designs and implements ad-hoc reports to meet specific customer requirements.

Pasadena, California

Direct the development of outcomes & process measures, including technical specifications, to enable population measurement, guideline implementation, & evaluation. Independently consult with project stakeholders to establish data needs, utilizing clinical and critical thinking skills. Construct complex data queries, utilizing different joins between tables, complex logic statements, mathematical equations, conditional statements, and statistical methods to turn data into useful information/knowledge. Provide statistical reports and analysis in formats that are clear and understandable for the audience intended. Coordinate the prioritization process for incoming data requests. Present data to teams, senior leadership, or other clinical groups, as requested.

Supervised team responsible for data entry, coordination of data clarification queries to investigational sites, data cleaning and updates to clinical data, filing of clinical data, creation of study specific data management documentation, and archiving of clinical information. Lead project team during corporate restructuring to centralize data coordination functions. Responsible for supporting diverse clinical studies in cardiac rhythm management and neuromodulation therapeutic areas for study teams in three locations. Developed enhancements and streamlining of business processes related to the clinical data flow. Hired and retained a diverse, highly qualified staff and responsible for providing career coaching, growth and personal development for direct report employees.

Responsibilities:• Managed dedicated team responsible for all phases of clinical research data management; Set priorities and goals, facilitated meetings, and monitored and evaluated performance and provided timely written and verbal feedback.• Utilized appropriate statistical methodology on a wide variety of studies and projects including pilot, pivotal, and post market studies conducted in the US, Canada, and the EU.• Created statistical plans, performed sample size calculations, statistical analyses, created tables and graphs, and assisted with final report and manuscript writing/editing.• Assisted project development by conducting literature reviews and presenting to diverse audiences.• As part of a clinical project team, created study protocols and case report forms.• Created and presented research posters at various industry conferences.• Supported clinical project teams through training on custom applications for study management, site monitoring, and reporting.Accomplishments:• Created dedicated in-house team to oversee all data management and biostatistical activities.• Lead project team to coordinate implementation of Oracle Clinical and internal study management software.

Plano, Texas

• Responsible for study site management during all phases of clinical study from site approach through close-out in compliance with applicable FDA regulations and Company operating procedures.• Primary sponsor contact for site personnel for all study issues.• Conducted site screenings; facilitated site start-up activities including budget discussions, IRB submissions, and acquiring regulatory documents; conducted site initiations and trainings.• Maintained regulatory binder with communication records and all required documentation.• Performed in-house and on-site monitoring of CRFs and source documents during study conduct; completed periodic monitoring visits and reports.• Conducted study close-out visits and ensured sites were audit ready and in compliance with applicable FDA regulations.

Mph, Biostatistics

Bs, Biology/Biological Sciences, General