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.

• Bachelors degree in a related area, or equivalent combination of experience, education and training

• Minimum three to five (3 - 5) years of experience with data systems and implementation in a multi-center clinical trials setting, and a superior understanding of the associated regulatory requirements this unique setting demands.

• Typically two or more (2+) years of experience managing others an information technology organization.

• Requires thorough knowledge of database management systems sufficient for strategic planning, technology assessment and direction.

• Requires knowledge of technical architecture, systems use, maintenance, and planning and integration strategies.

• Critical thinking, persuasion/ negotiation, mentoring, leadership/ management, problem solving, and human resource policies and procedures relating to management responsibilities.

• Quantitative and analytical abilities. Strong technical database systems management abilities.

• Experience in the management of ongoing technology infrastructure acquisition and expansion, to include the identification and integration of suitable emerging technologies.

• Thorough knowledge of technical concepts and basic operating principles of data communications, computer hardware, vendor IT products, and software.

• Ability to understand the process involved to adapt, integrate, and modify existing programs or vendor-supplied products for use within the technical environment.

• Experience of analyzing buy vs. build procurement for products for effective and efficient technology use.

• Excellent oral and written communication skills, including the ability to effectively present technical topics to individuals and groups with potentially varied levels of technical sophistication.

• Understanding of software development lifecycle, which includes discovery, requirements definition, design, development, testing and implementation.

• Ability to develop a mastery of the products and services developed and maintained by ADCS.

• Proven track record in management of projects with complex stakeholder interaction,including adherence to scope, schedule and issues management. Develop and maintain project plans.

• Master's degree in a related field (ex. Public Health, Health Information Management, Biomedical Informatics).
• Completion of Clinical Trials certification.
• SCDM-Certified Data Manager.
• CDISC knowledge and experience.

• Employment is subject to a criminal background check.

Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).

If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!

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