Clinical Database Programmer - Remote - 120604

This position has the ability to work 100% remote or hybrid/remote which would include working both onsite in La Jolla and remote.

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.

• 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 to communicate technical information to technical and non-technical personnel at various levels in the organization. Must have excellent written and oral communication skills.

• Demonstrated strong problem-solving skills. Able to learn effectively and meet deadlines. Demonstrated ability to prioritize tasks and redirect focus, reassess and change workflow as competing deadlines demand.

• Self-motivated and works independently and as part of a team.

• Strong organizational skills. Must be highly proficient at prioritizing workflow as demands dictate, in an environment with frequently shifting priorities.

• Strong analytical and design skills, including the ability to abstract information requirements from real-world processes to understand information flows in computer systems.

• A minimum of 3-5 years of study base build working experience in the pharmaceutical, biotechnology, medical device/diagnostic, CRO or Academic setting.

• Familiarity with data model patterns in one or more common business or academic domains.

• Familiarity with data quality and governance issues and requirements.

• Familiarity with logical data design and data mapping or data conversion.

• Experience working with Omnicomm/Anju Trial Master EDC.

• Must pass a background check.

• Must be willing to work outside of core business hours, including evenings and weekends as projects and deadlines dictate.

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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