Simona Ryabo Email & Phone Number

Exton, Pa, Us

Raleigh, North Carolina, Us

• Create the annotated case report form (aCRF) based upon the protocol • Review, revise and create processes for established and for the Clinical Data Management SOPs and Guidelines • Assist with maintenance of all relevant documentation associated with each assigned Protocol.• Build studies within clinical database using the related study documentation • Perform required testing within the clinical database • Perform and/or oversee database validation including generation of scripts, reports, execution of validation, and related documentation • Program edit checks within clinical database • Maintain the clinical database throughout the study • Ensure that appropriate study documentation related to the clinical database is filed • Provide database programming support for ad hoc listings and reports to Clinical Data Management

Raleigh, North Carolina, Us

• Providing support for the mapping and transformation of clinical data to CDISC SDTM standards. • Support multiple functional groups (i.e. Data Management, Statistical and Programing, etc) across all phases • Lead SDTM conversion activities across multiple studies concurrently • Lead and actively participate in review of SDTM conversion deliverables • Create & Maintain process documentation as required • Lead or participate in process redesign & optimization • SAS programming for creation / review of SDTM domains as required • Create “DEFINE.XML” document• Training of new staff on the role of SDTM programmer• Provide training/guidance on SDTM conversion process for teams • Other activities as required to support SDTM conversion and implementation of CDISC standards• Extract clinical data from the clinical data management system and produce standard and custom reports, primarily in SAS.• Program and generate reports and listings as requested by project team members for ongoing studies.• Develop transfer specifications with vendors for external data sources. Perform consistency checks on data transferred between Client and external parties to ensure completeness and accuracy of data contained transfers (generate reports of data reconciliation between eCRF and external data e.g., central LAB, PK , ECG, IWRS, DIARY)

• Wrote programs using SAS, COBOL, JCL, CICS, DB2, EASY TRIEVE - Participated in enhancement, programming, testing, and support of Customer Information System (Billing Department).Provided production support and maintenance of CIS system (Residential and small Commercial) PECO customers. Involved in statistical analysis of product consumption based on SAS/STAT procedures such as UNIVARIATE, MEANS, REG, CORR, FREQ, GLM, RANK, etc. Developed and executed monthly, quarterly, and annual financial reports for a new tariffs using PROC REPORT and Data _NULL_. Program validation. Graphical support for reports and presentationsby MS Excel and SAS/GRAPH. Programmed using SAS MACRO facility.Export/Import SAS Data sets. - Produced standards documentation according to user’s requirements. Assisted client with project requirements and developed technical and functional specifications. - Participated in 24 hours on-call rotation, researched and fixed current production problems, enhanced CIS System according with incoming Service Requests, created and executed Test Plan for programming changes. Worked with users on production problems determination. Analyzedbusiness requirements, prepared detailed and system documentation, specifications for program changes

Engineering

Bs