San Diego, California

Special Selection Applicants : Apply by 12/21/20. Eligible Special Selection clients should contact their Disability Counselor for assistance. 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 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 MINIMUM QUALIFICATIONS Bachelor's Degree in related area; and/or equivalent experience/training. Five (5+) or more years of senior-level research clinical data experience. Proficiency in computer programs or project management tools (Excel, Word, JIRA, MS Project, Confluence etc.) Requires knowledge of database management systems. OmniComm TrialMaster preferred. Ability to prepare complex data models unassisted. Ability to understand and model complex knowledge-intensive processes such as scholarly and research processes. Thorough knowledge of the data management process and experience in specialized data management skills (e.g., SAE reconciliation, central laboratory, and/or new technology.) Thorough understanding of FDA and regulatory environment as it pertains to data management. Proven experience in data integration and the specification of data services. Demonstrated modeling and information design 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 good negotiation and influencing skills. Ability to work with others from diverse backgrounds. Effective communication and interpersonal skills. Proven service orientation skills. Ability to communicate technical information to technical and non-technical personnel at various levels in the organization. Advanced problem-solving skills. Able to learn effectively and meet deadlines.Advanced analytical and design skills, including the ability to abstract information requirements from real-world processes to understand information flows in computer systems. PREFERRED QUALIFICATIONS Three (3) years of clinical data management experience in pharmaceutical industry, contract research organization and/or academic research organization. SPECIAL CONDITIONS

San Diego, California

Southern California HERC, established in 2003, is a non-profit organization composed of a diverse group of colleges and universities, and research, medical, and cultural institutions. Our institutions are committed to diversity, equity, and inclusion in the recruitment process and providing a work environment sensitive to work/life balance. We also understand that employment decisions often involve two careers and offer state of the art dual career resources and solutions. SoCal HERC includes members from the Central Coast, Los Angeles, Orange County, Inland Empire, and San Diego.

HERC is a gateway to more jobs in higher education and related fields than any other website. HERC provides job seekers with comprehensive and transparent access to job opportunities, daily job alerts, career advice news and webinars, dual career support, and regional multicultural resources to help with relocating to a new community.

SoCal HERC Member Institutions:

Antioch University, Azusa Pacific, University Cal Tech

CSU Fullerton, CSU Northridge,  CSU San Bernardino 

Cedars-Sinai Medical Center, Chapman University, Citrus College

Concordia University Irvine, Grossmont-Cuyamaca CCD, Kaiser Permanente School of Medicine 

Loyola Marymount University, MiraCosta Community College, Mount St. Mary’s University

North Orange County CCD, Occidental College,  Pacific Oaks College & Childrens School 

Point Loma Nazarene University, San Diego State University, Soka University of America

The Claremont Colleges, The Salk Institute for Biological Sciences, UC Path Center

UC Irvine, UCLA, UC Riverside

UCSD, University of Redlands, University of San Diego

University of Southern California, Vanguard University, Whittier College

While there are certainly wonderful opportunities to teach and conduct research at HERC campuses, of the 42,000 jobs on, over 24,000 (or 57%) are non-teaching positions. You will find jobs in healthcare, administration, software, information technology, finance, technical and trades, social work, student affairs, and much, much more.

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