Clinical Data Manager - Remote - 116790
As a federally-funded institution, UC San Diego Health maintains a marijuana and drug free campus. New employees are subject to drug screening.
#116790 Clinical Data Manager - RemoteExtended Review Date: Thu 12/1/2022
UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply.
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
Candidates hired into this position may have the option to work remotely.
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 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. The ADCS is funded by federal and private grants, contracts, and gift support. The ADCS is a unique center (ARO) at UCSD, which collaborates with internal and external stakeholders to forward its mission to discover, develop, and test, new drugs to treat patients with AD. Annual funding for the ADCS grant is approximately $10 million, with additional funding through industry partnerships totaling over $30 million.
Clinical Data Manager oversees clinical data management activities across multiple assigned studies. Performs thorough reviews of critical Clinical Data Management documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans. Performs User Acceptance Testing (UAT) on development of eCRFs and IRT systems during study build and post production changes. Review data transfers for consistency with available specifications. Performs supplemental data reviews according to the data quality checks outlined in the edit check specifications document.
Writes clear queries on missing data and data points failing pre-defined range checks and/or logical checks. Participates in reviews of blinded TFL output prior to final database locks. Creates and provides reports on the progress and status of the on-going study data management activities and deliverables, ensuring assigned projects are delivered on track with high quality and accuracy. Contributes to departmental compliance with regulatory and ICH guidelines, GCPs, Standard Operating Procedures, and CDM best practices.
Having significant experience, applies advanced data / information management concepts and campus / medical center / OP objectives to resolve highly complex issues where analyses of situations, information or data require an in-depth evaluation of variable factors. Selects methods and techniques to obtain desired results
Nine (9) years of related experience, education/training, OR a Bachelor’s degree in related area plus five (5) years of related experience/training.
Ability to prepare complex data models unassisted.
Ability to understand and model complex knowledge-intensive processes such as scholarly and research processes.
Experience in data integration and the specification of data services.
Proven modeling and information design skills.
Good negotiation and influencing skills.
Familiarity with highly complex logical data design and data mapping or data conversion.
Familiarity with highly complex data quality and governance issues and requirements.
Advanced knowledge of data management systems, practices and standards.
Thorough knowledge of relevant rules and regulations. Knowledgeable in ICH GCP standards, HIPAA and industry best practices and CDISC standards (CDASH, SDTM, ADaM).
Demonstrated ability to communicate technical information to technical and non-technical personnel at various levels in the organization.
Advanced analytical and design skills, including the ability to abstract information requirements from real-world processes to understand information flows in computer systems.
Ability to represent relevant information in abstract models. Critical thinking skills and attention to detail.
Thorough knowledge of the data management process and experience in specialized data management skills (e.g., SAE reconciliation, central laboratory, and/or new technology.
Requires knowledge of database management systems.
Understanding of FDA and regulatory environment as it pertains to data management.
Proficiency in computer programs or project management tools (Excel, Word, JIRA, MS Project, Confluence etc.)
- Three (3) years of clinical data management experience in pharmaceutical industry, contract research organization and/or academic research organization.
- Employment is subject to a criminal background check.
- Must be willing to work outside of normal business hours as necessary to meet deadlines.
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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