UCSD Layoff from Career Appointment: Apply by 9/26/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 10/06/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Candidates hired into this position may have the ability to work remotely.
The Alzheimer's Disease Cooperative Study (ADCS) is a growing, progressive, multi-center clinical trials consortium created to provide an operational framework for large scale Alzheimer's disease research projects and was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California, San Diego. The ADCS consists of 7 cores, 22 committees, ~40 research sites that are members of the consortium/Steering Committee, and an additional 30 or more research sites located across the U.S. and Canada that participate in one or more trials coordinated by the ADCS. Annual funding for the ADCS ranges from$10-$25M. The ADCS provides expertise in developing Alzheimer's disease related protocols and is the coordinating center for multiple clinical trials of varying sizes and complexity under subcontracts funded by NIH, the Alzheimer's Association, and clinical trial agreements with industry partners.
The Clinical Data Analyst is responsible for assisting Clinical Data Managers in ensuring data management activities are delivered in a complete, consistent, accurate and high quality manner for assigned studies. Works collaboratively with programmers, Clinical Operations, Clinical Monitoring, Biostatistics and others to meet study deliverables and timelines. The Clinical Data Analyst may act as the Data Management Lead on projects where required.
Works on research data reporting assignments that are of moderate diversity in scope. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Provides data review listings and metrics as requested by clinical and project teams. Reviews, analyzes, validates and maintains clinical trial data ensuring consistency, integrity and accuracy. Issues and manages queries based on programmed edit checks and the Data Management Plan. Assists in data transfer activities and performs vendor data reconciliation.
Assists in developing the clinical study database, including eCRF design, user requirements and edit check specifications. Performs User Acceptance Testing (UAT) prior to go-live and subsequent mid-study changes as needed. Ensures the clinical study database is ready to lock/freeze as appropriate for statistical review, interim review, and/or final database lock.
6 years of related experience, education/training, OR a Bachelor's degree in related area plus 2 years of related experience/training
Working knowledge of basic data management tasks including query reconciliation and data listing reviews.
Working skills in statistical analysis, systems programming, database design and data security measures.
Skills to communicate complex information in a clear and concise manner both verbally and in writing.
Demonstrated experience in data management coordinating center involving multiple large and complex research projects or studies, and demonstrated experience in databases design, development, management, and usage. Understanding of relational and object oriented databases, data and file types, and user interface design.
Experience in clinical data management and some Electronic Data Capture (EDC) systems.
Knowledge of GCP and 21 CFR Part 11 requirements regarding clinical data management documentation and software.
Knowledge with medical terminology, medications and research terminology, and standards including MedDRA, WHO Drug, and CDISC.
Excellent organizational and problem solving skills; strong attention to detail but ability to plan for long-term contingencies.
Proven ability to research, gather and organize information to produce clear and concise reports and presentations using various resources.
Basic familiarity with clinical research methodology and terminology to inform the development and review of research database and data management.
UC San Diego is an academic powerhouse and economic engine, recognized as one of the top 8 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom - life is their laboratory. UC San Diego's rich academic portfolio includes six undergraduate colleges, five academic divisions and five graduate and professional schools. The university's award-winning scholars are experts at the forefront of their fields with an impressive track record for achieving scientific, medical and technological breakthroughs.