Worldcare clinical

Pleasanton,CA, U.S.Canada

Essential Functions Review and assure the quality, integrity, accuracy, and completeness of clinical trial data based on project specific guidelines. Develop and maintain a library of effective data quality checks. Review data exports and reports to identify, investigate, and reconcile data discrepancies with Clinical Operations staff and/or clients Data Managers. Prepare, review, and upload appropriate Data Management documents to the Trial Master File Perform thorough development testing of the datasets prior to release to production, inclusive of creating test scripts and execute testing as applicable. Author Data Transfer specifications (DTS) for incoming and outgoing data files. Collaborate effectively and build productive relationships across the global operations team. Performs other job-related duties as assignedQualifications 3+ years of data management experience in the clinical trials industry BS/BA degree or professional experience equivalent. Demonstrated successful experience in all relevant clinical data management activities in a Pharmaceutical or CRO setting. Working knowledge of clinical trial research, including FDA, GCP/ICH guidelines, GDPR, CDISC/SDTM standards and 21 CFR Part 11 Experience working with EDC systems, e.g., Medidata Rave or Oracle Inform Familiarity with industry wide coding dictionaries such as MedDRA is a plus Experience with relational databases and XML a plus Excellent written and oral communication skills. Excellent analytical and problem-solving skills Ability to function independently. Ability to prioritize and handle multiple tasks and projects concurrently

Primary responsibilities are clinical programming and data analysis; understanding various data sources and coding programs to extract data into analysis-ready data sets; creation of software test plans and testing, and development of statistical analysis reports. Data analysis includes descriptive analysis of Independent Reader performance and other metrics to assess the quality of services offered by WCC. Clinical Programmer works closely with Project Managers, Software Developers and Clients regarding data quality and data transfers.Essential Functions Lead clinical programming aspects of WCC clinical trials, including consulting with external statistical consultants. Analyze existing and new programs, processes and databases to identify and/or guide implementation of modifications aimed at increasing workflow efficiency. Develop SAS databases, when applicable Review and assure the quality, integrity, accuracy, and completeness of clinical trial data based on project specific guidelines. Develop and implement quality review of data using SAS data validation programs. Standardize datasets to ensure compliance with data transfer requirements and enhance usability. Develop programs and guide efforts to perform robust data manipulation and error detection to ensure data integrity. Extract data from the WCC trial system and provide analytical reporting. Review data exports and reports to identify, investigate and reconcile data discrepancies with Clinical Operations staff and/or clients Data Managers. Implement variability testing criteria to monitor Independent Reader performance. Author and review Data Transfer Files specifications (DTF) for incoming and outgoing data files. Respond to client requests for additional data and/or data analysis, as needed. Collaborate effectively and build productive relationships within across the global operations team. Performs other job-related duties as assigned.