Erin Erginer Email & Phone Number

Direct team of 5 managers responsible for the acquisition of complex biomarker, imaging, and eCOA data across phases and therapeutic area.• Brokered a proposal that reduced team impact during major layoffs by 80%.• Spearheaded collaboration with various project team members, including data management, clinical, data standards, statistics and programming, and laboratory personnel.• Developed metrics to measure success and track the metrics during the project and formulated action plans against any deviations.• Formulated external vendor data strategy for implementation of 2 major database solutions (Oracle DMW and Veeva CDB) from proof of concept through implementation.

Operated as a subject matter specialist for clinical evidence presented beyond the EDC framework, including safety laboratories, biomarkers, imaging, eCOA, immunogenicity, and genetics.• Oversaw case report tabulation packages for FDA submission provided by third party vendors in CDISC/SDTM format, as well as supervised 100% of trials with the successful delivery of CRT package within the assigned time frame.• Created RACI and process flow diagrams for new business initiatives.

Raleigh-Durham, North Carolina Area

Directed a team of 5 programming and data management direct reports, overseeing the acquisition of external vendor data for an average of 30 early-phase clinical trials/year.• Manage embedded functional service provider team that handles third party vendor data for early phase trials across multiple therapeutic areas• Line manager for employees across multiple functions including data management, external data management, and clinical programming• Participate in business development by presenting at bid defense• Serve as point of contact with sponsor for issue escalation and resolution • Review resource requirement prediction metrics and create allocation plan to meet changing needs of the sponsor, and participate in hiring and onboarding of staff• Design and implement training plan, quality review process, and metric strategy for data management work conducted by India-based team• Lead team meetings and 1:1 mentoring sessions for employee development, review performance, implement performance improvement plans, and set development goals • Develop technical processes and training materials for DOCS GSK Data Management • Subject matter expert for tools and applications used for dataset creation and modification, edit checks, quality review, and external data processing• Lead vendor management oversight including communication, monitoring timelines and budgets, and ensuring adherence to regulatory requirements• Lead review of protocol, dataset specification, nominal time specification, data validation specification, and eCRFs as related to external data • Collaborate with data standards, clinical team, and statistical programmers to ensure specifications align with study objectives and CDISC standards

Raleigh-Durham, North Carolina Area

Assured clinical operations delivery, manages the escalated project and site-related matters to drive follow-up action plans and improve departmental procedures. Lead data manager of early phase clinical trials from final protocol to database freeze• Process, clean, reconcile, and review data collected on electronic case report forms and data transferred electronically from third party vendors• Create Data Validation Specification and test scripts• Oversee user acceptance testing of electronic case report forms• Design and validate new programmatic checks, edit SAS and SQL code • Create and maintain datasets, variables, and code lists driven by the protocol• Operate data management tools, review edit checks, and manage queries• Work with software tools designed to process and validate data outside of EDC system

Raleigh-Durham, North Carolina Area

-Data analysis, database organization, error reconciliation, generation of reports-Project coordination, protocol creation and modification, supply management-Processing and analysis of human specimens for various grant-based research projects

Greensboro/Winston-Salem, North Carolina Area

-Process medical cytology specimens in a clinical cytology department-Perform molecular testing including microbial specimen identification & classification-Assist with CAP Accreditation checklists and editing of printed laboratory materials

Erie, Pennsylvania

Bachelor Of Science (B.S.), Biology, General

Certificate, Clinical Trials Database Management, 4.0

Certificate, Measuring And Improving Business Performance

High School Diploma