Clinical Programming Analyst
Advanced Clinical Holdings, LLC seeks Analyst, Clinical Programming in Deerfield, Illinois (and other U.S. locations, as needed).
With general direction, work with the Clinical Science Units (CSUs) or Business Units (BUs) to understand the data requirements for collection and submission. Perform Peer review of Clinical Database Programming deliverables in different EDC systems. Automate QC processes by programming reports in Pl/ SQL and Business Objects. Independently develop and maintain all standard objects, procedures, templates and views for Oracle Clinical standard Global Library. Support or lead a special project (limited in scale and scope) both clinical and non-clinical in nature. With general direction, define the data content and structures for collection, transformation and CDISC SDTM submission requirements in Clinical Data Standards of moderate level of complexity. With general direction, perform impact analysis for proposed modifications to existing clinical study databases. Independently develop, test and maintain all Global Library objects needed for clinical studies. Document, develop, review and maintain Global Library Copy Groups of DCMs, DCIs, procedures, views and DCI books for reuse of standard pages in individual trials. Seek process improvement and incorporation of newly discovered practices towards maintenance of Global Conventions for data modeling/standards and clinical study design. Analyze clinical programming process maps to determine efficiency in processes. Create processes to ensure quality. Contribute to the review of global SOPs and business guidance's/user guides directly impacting the function and providing input when applicable. Document, develop, test and maintain OC validations and derivations procedures using PL/SQL. Maintain Form Layout Templates, Extract Macros and Key Templates for use in individual trials. Perform Quality Control activities on Global library objects with each release of Global standards. Train less experienced associates on specific tasks relating to client's Clinical Data Standards and/or Global Library Processes. Subject matter expert in Oracle Clinical and Global Librarian processes. Act as a consultant to CSU/BU for client's Clinical Data Standards and OC/RDC setup, including validation procedure development.
Requires a Bachelor's degree in a Life Science, Computer Science, Mathematics or related field plus 5 years of experience or a Master's degree in a Life Science, Computer Science, Mathematics or related field plus 3 years of experience. Experience with the setup of clinical databases and with CRF design, gained in the pharmaceutical industry or in a CRO. Experience with the implementation of CDISC standards, and an understanding of clinical data management systems or relational databases, as applied to clinical trials. Knowledge of SQL or PL/SQL. Experience with the development of validation and derivation procedures. Experience with OC/RDC and the development of objects in the OC global library. Requires travel to other domestic work sites.
Must also have authority to work permanently in the U.S.
Applicants who are interested in this position may apply online at www.jobpostingtoday.com, reference # 2164, for consideration.
Advanced Group is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.
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