Payroll Title:
DATA SYS MGR 1 Department:
NEUROSCIENCES Salary Range
Commensurate with Experience Worksite:
La Jolla Appointment Type:
Career Appointment Percent:
100% Union:
Uncovered Total Openings:
1 Work Schedule:
Days, 8 hrs/day, Monday-Friday
As a federally-funded institution, UC San Diego Health maintains a marijuana and drug free campus. New employees are subject to drug screening.
#118720 Director, Data Management - Hybrid/Remote
Filing Deadline: Tue 9/20/2022
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For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy
Special Selection Applicants: Apply by 11/03/2021. Eligible Special Selection clients should contact their Disability Counselor for assistance.
DESCRIPTION
The Alzheimers Disease Cooperative Study (ADCS) is a multi-center clinical trials consortium created to provide an operational framework for large scale Alzheimers disease (AD) research projects. The ADCS is a growing, progressive, multi-tiered organization which administers numerous clinical trials at over 60 sites with federal and private grant, contract, and gift support. The ADCS is a unique center at UCSD, and collaborates with internal and external stakeholders to forward its mission to discover, develop, and test, new drugs to treat patients with AD.
The Director, Data Management is responsible for the leadership of the Data Management and Informatics Core that is accountable for the architecture, design, deployment, and operation of the information capabilities of the organization. The core has end-to-end ownership of the ADCS Clinical Data Management System (CDMS), data warehouse/reporting, data quality, data governance, and delivery and support of clinical data management and business intelligence tools.
This role provides strategic direction and oversight for the design, development, operation and support of data management capabilities that fulfill the needs of the organization. Develops and applies metrics and data analysis to identify and implement process, quality, and system improvements. Leads initiatives focused on defining/maintaining clinical data standards and executing a Data Quality Assurance program to ensure data collection, integration, transformation, and usage occur accurately and consistently. Develops and designs data production processes as needed.
Directs the scope of work, design, and management of the ADCS Clinical Data Management System (CDMS) comprising the electronic data capture portal (EDC), clinical trial management system (CTMS), API services for integration with in-house developed applications for image management, investigational product management, data transfer/transformation, analytics/reporting, and plans, develops, and implements the acquisition and storage of data and metadata through ADCS legacy data sharing portals (~30 portals). Also responsible for data curation and security monitoring of ADCS legacy data portals (~30).
Responsible for planning and executing data transfers from external sources to ADCS-hosted cloud-based environments. Ensures integrity and completeness of data as well as develops workflows, guidelines, data pipelines, and data dictionaries. Product manages the development process through the software development lifecycle: discovery, requirements definition, design, development, testing and implementation to provide a robust and flexible data management infrastructure that complies with 21 CFR Part 11, HIPAA, GCP, and other regulations relevant to clinical trials management.
The Director is responsible for the oversight of computer system validation (CSV) initiatives to ensure that relevant computer systems are in compliance with applicable regulations including FDA Title 21 Code of Federal Regulations (CFR) Part 11. Other responsibilities include the review and approval of validation deliverables and Software Development Life Cycle (SDLC) documents, as well as development of data management and Informatics SOPs and best practices.
Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Reviews and approves recommendations for functional programs. Provides guidance to subordinates to achieve goals in accordance with established policies. Erroneous decisions or failure to achieve goals would result in additional costs to the center and department, serious delays in overall timelines, and would require hiring additional personnel. In addition, failure to achieve goals would potentially create negative consequences to the ADCS network of sites.
This position may be approved to work a hybrid schedule which includes a combination of working both onsite in La Jolla and remote.
MINIMUM QUALIFICATIONS
Location: La Jolla, CA
Posted: Oct. 21, 2024, 9:24 p.m.
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