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