• Mentored data management and solutions staff (domestic and international) with documentation, development / testing, and system launch.• Participated in requirements definition sessions with stakeholders to capture business requirements.• Gathered requirements through interviews / meetings, document analysis, surveys, site visits, business process descriptions, use cases, and workflow analysis.• Drafted data management and validation documents. Wrote and reviewed test plans, cases, and scripts against requirements documentation to ensure full requirements-testing traceability.• Facilitated and managed review and approval of test results and all data management and validation documents.• Worked closely with project management and software developers to formulate high-level technical solutions.Identified, coordinated, and implemented process improvement initiatives.

• Mentored data management and solutions staff (domestic and international) with documentation, development / testing, and system launch.• Participated in requirements definition sessions with stakeholders to capture business requirements.• Gathered requirements through interviews / meetings, document analysis, surveys, site visits, business process descriptions, use cases, and workflow analysis.• Drafted data management and validation documents. Wrote and reviewed test plans, cases, and scripts against requirements documentation to ensure full requirements-testing traceability.• Facilitated and managed review and approval of test results and all data management and validation documents.• Worked closely with project management and software developers to formulate high-level technical solutions.Identified, coordinated, and implemented process improvement initiatives.

• Generated, resolved, and tracked queries to address problematic data identified during data review activities.• Applied quality control procedures and checks to achieve client and company data quality standards.• Reviewed clinical trial data in accordance with data management plans and applicable standardized data management procedures (SOPs, work instructions) to identify erroneous, missing, or incomplete data.

• Participate in internal/external project team meetings updating the study status• Create Data Validation Specifications (Edit check) documents• Work with off shore personnel on edit checks, data entry and reconciliation processes• Review and clean data, including creating edit checks• Create Data Entry Guidelines• Create Data Management Plan• Reconcile Adverse Events and Concomitant MedicationsAnnotate Case Report Forms