DESCRIPTION

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.

Incumbent understands and translates business needs into data models supporting long-term solutions, including creating data archiving and management plans, ensuring the integrity of the data, and that data flows and stores are controlled, accurate, and consistent. Incumbent will identify the cloud infrastructure design to best optimize and support business growth; develop 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. In addition, incumbent will 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. Other responsibilities include requirement gathering, prototyping, architecting tools and systems.

MINIMUM QUALIFICATIONS

• Seven (7) years of related experience, education/training, OR an Bachelor's degree in related area plus three (3) years of related experience/training.

• A minimum of three to five (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 logical data design and data mapping or data conversion.

• Familiarity with data quality and governance issues and requirements.

• Ability to represent relevant information in abstract models. Ability to convey complex data and systems architecture, information, and data management related concepts to a lay audience, especially to center leadership.

• Thorough knowledge of data management systems, practices and standards. Specifically pertaining to multi-center clinical trials.

• Thorough knowledge of relevant rules and regulations. Including regulatory requirements pertaining to clinical trials such as HIPAA compliance, Part 11 Compliance, and GCP.

• 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.

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

• Experience working with data and systems pertaining to multi-center clinical trials and the special considerations for data integrity, maintaining the blind, as well as regulatory requirements pertaining to multi-center clinical trials is required.

PREFERRED QUALIFICATIONS

• Experience working with Omnicomm/Anju Trial Master EDC.

SPECIAL CONDITIONS

• Employment is subject to a criminal backgr