Career Center
West Harrison, New York
Syracuse, New York
Georgetown, Kentucky
Philadelphia, Pennsylvania
Omaha, Nebraska
Posted: 13-Dec-22
Location: La Jolla, California
Salary: Open
Internal Number: 120604
UCSD Layoff from Career Appointment: Apply by 12/13/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 11/22/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position has the ability to work 100% remote or hybrid/remote which would include working both onsite in La Jolla and remote.
Placement within the salary range is determined by internal equity, relevant qualifications, and collective bargaining agreements (when applicable).
DESCRIPTION
The Alzheimer's Disease Cooperative Study (ADCS) was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California, San Diego. The ADCS is a multi-center clinical trials consortium that provides an operational framework for large scale Alzheimer's disease research projects. The ADCS consists of 7 cores, 22 committees, 35 research sites that are members of the consortium/Steering Committee, and an additional 40 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 $15-25M. 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 and clinical trial agreements with industry partners.
Applies skills as a seasoned, experienced clinical research programming professional with full understanding of industry practices and clinical research methodologies, policies and procedures to resolve complex technical and programming issues where analyses of situations or data requires a review of a variety of factors. Demonstrates competency in selecting methods and techniques to obtain solutions.
The incumbent understands and translates business needs into data models supporting long-term solutions, including creating, developing, and programming end-to-end electronic case report forms (eCRFs) and all associated edit checks, creating relevant EDC-related data archiving and management plans, ensuring the integrity of the data, and that data flows, and stores are controlled, accurate, and consistent. The incumbent may assist in developing architecture blueprints, and detailed documentation based on need assessment for data integration and curation methodologies and work with leadership to implement them for the center.
The incumbent will be an integral part of the data management team, participating in team discussions revolving around study design and database structure, suggestions for data flow, and full participation in the User Acceptance Testing (UAT) of each new study for all database updates. In addition, the incumbent will help to set standards and create SOPs to improve the quality of data and develop a data curation and archiving plan for clinical trial data as well as legacy data and information systems data that adheres to regulatory requirements, HIPAA, CFR Part 11, and GCP.
MINIMUM QUALIFICATIONS
Bachelor's degree in computer science or equivalent combination of related education and experience.
Three (3) or more years of relevant experience, preferably a minimum of 3-5 years of clinical study database building, designing, and testing.
Work experience in the pharmaceutical, biotechnology, medical device/diagnostic, CRO or Academic setting.
Ability to prepare data models unassisted. Including CRFs and program editing checks.
Ability to design a study database based on minimum input from the team but reference to study protocol.
Ability to represent relevant information in abstract models. Demonstrated ability to convey complex data and systems architecture, information, and data management related concepts to a lay audience, especially to center leadership.
Ability to represent relevant information in abstract models. Critical thinking skills and attention to detail.
Thorough knowledge of data management systems, practices and standards. Specifically pertaining to multi-center clinical trials and the special considerations for data integrity, maintaining the blind, as well as regulatory requirements.
Thorough knowledge of relevant rules and regulations. Including regulatory requirements pertaining to clinical trials such as HIPAA compliance, Part 11 Compliance, and GCP.
Demonstrated ability to work with others from diverse backgrounds. Demonstrated effective communication and interpersonal skills. Demonstrated service orientation skills.
Demonstrated ability
Connections working at University of California San DiegoUC 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.More Jobs from This Employerhttps://careers.advamed.org/jobs/17907155/clinical-database-programmer-remote
