Quality Control Data

Sameera Fatima

Phone: 512-***-****

Austin, TX

Email: ******@*****.***

Objective

Combine resourcefulness and problem solving skills with more than six years of clinical and healthcare data management and research experience in delivering quality results. Team player dedicated to quality, detail oriented and bottom-line objectives.

Qualifications and Highlights

• Collected, organized, analyzed, and prepared materials in response to requests for information and reports written reports related to HIV/AIDS/STD epidemiology.

• Experienced with designing data reports using complex, relational databases.

• Experienced with research & evaluation methods, statistics, and data collection. Successfully evaluated and interpreted data outputs and statistical information.

• Determined the appropriate formats for epidemiological reports and coordinated with the technical preparation, graphics design, and compilation of finished reports

• Independently performed CRF design review; query generation and resolution against established data review guidelines.

• Successfully locked multiple large databases as part of Data Management team for some of the most renowned pharmaceutical companies in PhaseI through PhaseIII clinical trials.

• Performed quality control on IRB regulatory documents, data management plan (DMP) and maintained all the budget related activities.

• Experienced with ORACLE CLINICAL to resolve data discrepancy issues.

• Experienced in data transformations and edit checks in analyzing Case Report Form (CRF) data.

• Experienced in SAS programming for clinical trial data and producing TLG’s

• Experienced in using various SAS tools: SAS/BASE, SAS/ODS, SAS SQL and SAS Enterprise Guide with Oracle database and SQL.

• Well versed with performing coding with SAS in producing external files and reports, employing various SAS procedures like PROC Report, PROC Tabulate using ODS.

• Experienced in storing and managing data SAS files, using different types of Merge statements, Do-Loops, Arrays, SAS Formats and SAS Informats.

• Provide programming support to compress data from a multiple listing of a single subject data into a single listing using Arrays and Do Loops.

• Skills: SAS,SQL, ORACLE CLINICAL, ACCESS,EXCEL,ACCELIANT

Professional Experience

Dept of State Health Services

Program Specialist Aug 2012-current

• Manages data and develops databases. Coordinates epidemiological data collection operations, defines database requirements, and provides quality control for data management of epidemiological investigations.

• Manages data and develops databases using ACCESS.

• Coordinates epidemiological data collection operations, defines database requirements, and provides quality control for data management of epidemiological investigations.

• Develops and manages databases in order to perform advanced (senior-level) analytic work with epidemiologic and programmatic SAS data sets

• Writes scripts to process data in SAS and export the processed datasets to database created. .

• Develop SAS code which performs data cleaning, manipulation and statistical analyses using SAS

• Examines system documentation and specifications, source code, data files, and disparate written documentation and creates narratives, record layouts, and code books to fully characterize the datasets so that reliable and valid analyses and interpretations can be done by other epidemiologists and statisticians.

• Creates system files for statistical programs from exported source data files, includes appropriate labels and documentation for data.

• Written SAS codes which performs data cleaning, manipulation and statistical analyses using SAS

• Maintains master files of most commonly used datasets and makes them available to other epidemiologists in the Branch.

• Experience with designing data reports using complex, relational data bases.

PPD

Clinical Data Manager I April 2008-Aug 2008

• Prepared Annotated CRF for database testing prior to production.

• Reviewed SAS generated outputs for edit check specifications and for generating Queries.

• Prepared and reviewed Database specification Table.

• Prepared Mockup CRF of the E-CRF for database testing/production.

• Designed CRF using Adobe Pagemaker.

• Performed a compare of the A-CRF and Data Dictionary prior to coding

• Reviewed Electronic Edit Check Specification for database design and testing.

• Prepared and Updated error report for the QC’d data with MS-ACCESS prior to the Softlock of the Database.

• Prepared and maintained DMP.

Chiltern International

Clinical Data Manager I Jan 2008-April 2008

• Reviewed case report forms and data listings for legibility, completeness, and consistency.

• Completed database lock for various clinical trial studies in PhaseI and PhaseII.

• Supervised CDA’s for various data management activities with regards to case report forms for subsequent data entry and data discrepancy resolutions.

• Addressed edit-check reports for disposition of data queries in the Database.

• Resolved the queries generated using ORACLE CLINICAL.

• Generated drafts for the queries which needed to be sent out to the investigator sites using OC.

• Performed a quality control check on the SAS listings for consistency and accuracy.

Cedra Clinical Research

Quality Control Auditor Sep 2007-Jan 2008

• Reviewed Case Report Form (CRF) data for completeness, accuracy, and consistency, identified and resolved data discrepancies, generated and resolved data queries using ORACLE CLINICAL and ACCELIANT.

• Updated/corrected/reviewed data in clinical databases, assisted with the testing of data entry screens, assisted with the validation of edit check programs, updated tracking systems (CRFs, queries), maintained study files, performed data listings review, developed and updated Data Management.

• Performed quality review on queries generated by team members, dispatched queries to investigator sites and communicated with project team members.

• Experienced in writing sponsor communication letters.

• Verified informed consent procedures and protocol requirements are adhered to the applicable regulatory requirements.

• Ensured the consistency and integrity of the data submitted on CRFs or other data collection tools by careful source document review.

• Ensured study compound inventory and accountability documents are accurate and that study materials are stored securely per protocol specification.

Education

M.S. Biostatistics Texas A&M University (08/2011 – current )

B.S. Biochemistry Texas State University. (08/2004 – 08/2007)

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