University of Rochester CHET Director of Data Management & Info Systems - 221233 in Rochester, New York
CHET Director of Data Management & Info Systems Job ID 221233
School of Medicine & Dentistry
Full/Part Time Full-TimeFavorite Job
Full Time 40 hours Grade 055 Neuro-Ctr Health & Tech/CTCC
8 AM-5 PM; OCC WKENDS
The Center for Health + Technology (CHeT) is a research organization within the University of Rochester that aims to enable anyone anywhere to receive care and participate in research.
CHeT seeks to improve health globally through rigorous clinical studies and novel applications of technology. In support of its mission, CHeT does the following:
Designs and conducts large scale observational studies and FDA regulated clinical trials aimed at developing new treatments primarily for neurological disorders, such as Parkinson disease and Huntington disease
Leads project and data management efforts for NIH, foundation, and industry (e.g., pharmaceutical) sponsored studies
Applies technology, including those in telehealth, to develop better ways of providing care, advancing knowledge, and conducting research
Over the past 30 years, CHeT has conducted over 100 studies and enrolled over 40,000 participants, leading to seven FDA-approved drugs for Parkinson’s disease, Huntington disease, and other neurological conditions.
The Director of Data Management and Information Systems will be a member of the senior management staff of CHET and manage up to 15-20 individuals, including database managers, clinical data managers, programmers, data control clerks, the server team, desktop support and administrative staff. The Director will oversee data management activities for CHeT, interact with study sponsors (including executives at the respective foundations and pharmaceutical firms), and ensure data management needs of studies are met.
Key responsibilities include the following:
Manages and oversees all aspects of the entire data management area, and serves as the center representative and principal contact with new and prospective trial sponsors with regards to database and data management issues. Provides information systems analysis and area expertise required to support the implementation of department-wide information systems and new business initiatives. Conducts feasibility studies, prepares analyses, and presents recommendations. Provides direction and training to both internal and external resources required to ensure successful project and study completion. Allocates and assigns technical resources to meet departmental project needs. Consults with and advises users of the various databases and files.
Directs, manages, and controls all database management activities, as well as multiple file structures, including responsibility for their security and efficient operation. Formulates and prepares project plans with activities, dependencies, dates and timeframes, resource requirements, milestones and deliverables. Monitors progress of project activities and ensures all critical implementation criteria are met and provides status reports to steering committees.
Establishes and subsequently monitors standards and procedures to ensure integration of systems through database design. Drives key strategic initiatives including, recruiting, developing, training and retaining strong talent; driving improvements in technologies, databases, operating systems, and processes for clinical trial management; developing and executive strategic technology roadmap to enable efficient operations; delivering transparency into operations, including leading the team to develop timeline/resource dashboard to manage project timeline and optimize resource allocations.
Maintains responsibility for the definition, organization and documentation of all databases and data structures. Manages and implements training associated with activities performed in the conduct of clinical trials. Represents CHET / CTCC with external site management organizations. Demonstrates in-depth knowledge in area of expertise and integrates this knowledge with strategic plans. Participates in training and educational activities and presents and trains others in order to maintain expertise in rapidly changing environment. Utilizes information to assure effective and efficient technology decisions.
Ensures quality assurance for all data management activities. Evaluates database structures and promotes standardization in programming references to the database or other standards as necessary. Leads the team and collaborates with other Leaders to ensure appropriate systems documentation.
Fulfill additional responsibilities as requested by manager
Minimum requirements of a Bachelor’s degree in computer science, information technology, business, mathematics, statistics, science, engineering, or related discipline and at least 4-5 years of related experience with major hierarchical database or major rational data base packages, communication and distributed systems, including 3-4 years’ experience in a leadership or management role; or an equivalent combination of education and experience.
Master’s degree in technological or business discipline and 7-8 years’ experience in database management, information technology, or related field strongly preferred, including data management processes, programs, databases, systems, specific to the conduct of sponsored clinical trials, including electronic clinical systems, data visualization software, etc.
Experience in pharmaceutical industry desired, including experience with clinical trials terminology, Good Clinical Practice guidelines, FDA clinical regulatory guidelines, relational database software and application programming, NDA or CANDA electronic reporting, coding dictionaries (COSTART/WHOART, ICD-10, MedDRA), and source documentation procedures
Strong interpersonal, presentation and communication skills, including technical writing ability.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled