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Clinical programmer

Design Specialists

This is a Full-time position in South San Francisco, CA posted December 17, 2019.

Clinical Programmer II 9612509 Work is ON-SITE in SOUTH SAN FRANCISCO W2 ONLY 12 Month Contract Required Skills: CASE REPORTCASE REPORT FORMSCODINGCRFCUSTOMER SERVICE The Clinical Programmer within the USMA Data Management team is accountable for a number of deliverables and activities involving study set up in EDC.

This role requires the individual to have knowledge of clinical trials and Clinical Data Management, be technically competent, and possess excellent customer service skills and a desire to engage customers in pursuit of new business opportunities.

Knowledge & Accountabilities include but not limited to: Excellent knowledge of Medidata Rave and proficient in study database build; eCRF design, edit check and custom function programming, Amendment Manager, lab administration, PDF Generator, study account requests, global volumes, data validation specifications Knowledge of Medrio and proficient in study design and configuration Must possess good working knowledge of Clinical Data Management study start-up, conduct and close out, and understanding of the study management team’s role and processes in study development Provides EDC system and study design expertise to lead Study Data Manager to ensure data collection and visit schedule as defined in the protocol are implemented correctly Knowledge of data standards and adheres to their implementation in study design via use of the Global Standard Libraries and delivery of SDTM datasets Ensures data quality by performing validation of study builds including Case Report Forms (CRF), folders, matrices, edit checks, custom functions; maintains clean data validation specifications for development and release to UAT Monitor live studies to ensure any proposed changes to study design result in completeness and accuracy of clinical data and study-build changes are documented Analyze impact of EDC system enhancements on existing and new studies Provide support and technical assistance to other database build programmers, Study Data Manager, Clinical Programmers – SDTM and study management team Adheres to USMA CDM processes and follows department SOPs Competencies Experience with a programming language such as SQL, PL/SQL, C# or SAS and significant experience in clinical study database setup and edit check programming Strong planning and organizational skills and the ability to manage multiple priorities, tasks or goals, developing and committing to realistic estimates and plans to complete required tasks Technical proficiency and the ability to complete complex assignments within defined parameters Effectively communicates ideas, project goals and status of work on-time or in advance Ability to be flexible in approach to resolve issues and move forward Ability to work under minimal guidance Ability to articulate functional knowledge in the development of processes, training and related documents Experience with Microsoft Excel, Microsoft Word, Google Drive suite including Sheets, Docs, Slides, Diagrams Additional Skills: DATABASESDATASETSDRUG SAFETYEXCELLENT CUSTOMER SERVICE SKILLSSASSQLCLINICAL STUDIESCLINICAL STUDYCONDITIONAL RANDOM FIELDCUSTOMER SERVICE ORIENTEDDATA MANAGEMENTINTEGRATIONINTEGRATORRETAIL SALESSERIAL ATTACHED SCSISIEBELTECHNICAL ASSISTANCETRAINING