New

Data Analyst II

Spectraforce Technologies
United States, California, Sylmar
Jan 29, 2025
Title: Clinical Data Systems Analyst II Location: Sylmar, CA 91342 (Potentially become a Hybrid role but will be all onsite to start with) Duration: 12 Months with possible extension Responsibilities: Proficient experience in training to various sized audiences on applications and/or reports including training set-up, training documentation, live training, training recordings, utilizing training tools including PowerPoint. Will be Subject Matter Expert (SME) in one or more applications. Proficient Support Line contact addressing requestor's issues in a timely and efficient manner delegating to proper CDSA as needed. Proficient ability to communicate technical items to non-technical audiences. May perform proficient Global System Librarian responsibilities. Proficient understanding of clinical data collection tools with an emphasis on Oracle Clinical and Oracle Clinical's Remote Data Capture (RDC) system Proficient ability to support new and existing study database set-up (RDC and paper); understanding of Case Report Form (CRF) design, edit check specifications and system components that relate to the design and integrity of the database for data collection of a study. Proficient experience with Software Development Lifecycle (SDLC). Follows and provides input to Departmental Standard Operating Procedures (SOPs), Departmental Work Instruction (DWIs), and guidelines. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Proficient knowledge and complies with Good Clinical Practices (GCP), US Food and Drug Administration (FDA) regulations, International Conference on Harmonization (ICH), ISO 14155, other regulatory requirements, applicable company policies, operating procures and processes. Experience and Requirements: Education: Bachelor's degree required in any Business discipline such as Business, Computer Science, Communication, Health Sciences field, etc. Min 3 years of experience Organizational and proficient project management skills, as well as attention to detail. Program Management Professional (PMP) certification is desired. Highly skilled with Microsoft office products including Word, Excel, and Access. Proficient ability to work with database management systems. Proficient knowledge of database terminology and technology. Preferred knowledge of Relational Databases and demonstrated ability to generate queries using Query languages like Structured Query Language (SQL). Proficient knowledge and experience in supporting the building of clinical trial databases using Oracle. Clinical or equivalent. Proficient knowledge and experience building/customizing Clinical Trial Management Software Applications.