Job Description

Payroll Title:
RSCH DATA ANL 2
Department:
NEUROSCIENCES
Salary Range
Commensurate with Experience
Worksite:
La Jolla
Appointment Type:
Career
Appointment Percent:
100%
Union:
Uncovered
Total Openings:
1
Work Schedule:
Days, 9 hour shifts, 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.

#118983 Clinical Trials Data Analyst (Data Management)

Filing Deadline: Thu 10/6/2022

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

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.

DESCRIPTION

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.

MINIMUM QUALIFICATIONS

  • 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.

  • Working skills in analysis and consultation. Some experience with statistical and data management programming (Python,R, JavaScript, Jupyter Notebook) and the use of statistical software skills for database management, quality assurance anddata analysis.

  • 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.

PREFERRED QUALIFICATIONS

  • Basic familiarity with clinical research methodology and terminology to inform the development and review of research database and data management.

SPECIAL CONDITIONS

  • Employment is subject to a criminal background check.

  • Must be willing to work outside of normal business hours, including evenings and weekends to meet (clinical trial) deadlines as needed.


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!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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