University of Rochester Senior Manager, Data Management/Manager, Data Management - 229343 in Rochester, New York
Senior Manager, Data Management/Manager, Data Management Job ID 229343Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 055 Path&Lab Clinical TrialsSchedule
8 AM-4:30 PMResponsibilities
POSITION SUMMARY :
Manages and oversees all aspects of the Data Management group, and serves as the UR Central Laboratory representative and the main point of contact with new and prospective clients 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.
SUPERVISION AND DIRECTION RECEIVED:
Reports to the Administrative Director, Clinical Trials
SUPERVISION AND DIRECTION EXCERCISED:
JOB RESPONSIBILITIES :
Allocates and assigns technical resources to meet departmental project needs.
Leads the team and collaborates with other Leaders to ensure appropriate systems documentation.
Translates hospital and departmental policies into effective procedures, and communicates policies effectively.
Provides daily operational and technical guidance to staff .
Oversees performance evaluation process; insures fair and accurate evaluation following laboratory standards of performance. Provides counseling and constructive feedback for employee development.
Demonstrates initiative, and improves operational and financial performance through effective decision-making, planning and implementation skills. Encourages open expression of ideas and suggestions.
Data Management (30%)
Conducts feasibility studies, prepares analyses, and presents recommendations.
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 data management 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.
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 UR Central Laboratory with external 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.
Maintain Clinical Trials Management System – ClinAxys (20%)
Creates and maintains test dictionaries
Configures reference ranges and flags
Prepares and maintains system documentation
Creates system reports and data queries
Manage system security settings and user accounts
Participates in work flow design and improvement initiatives, and evaluates the most effective use of software to meet department objectives
Ensures system compliance with federal regulations in collaboration with quality staff
Maintains interfaces with SoftLab and clinical trials laboratory instrumentation
Communicates system status to department management
Provides first level user support; basic troubleshooting; answers questions about system functionality from internal staff, external customers and potential clients.
Oversee validation efforts (10%)
Enforces change management procedures
Communicates changes to system software and interfaces with vendors
Evaluates release notes and system specifications to determine validation requirements
Writes study validation plans and summary reports
Validates study parameters; collaborates with project managers on the design of study test cases, sets up cases and environment for study validation.
Train staff for effective use of CTMS features (10%)
Provides system training and usage overviews for staff
Assists in the development of standard operating procedures for system usage
Evaluates user guides provided by software vendors and creates site specific addendums
Other related duties and projects as assigned
Bachelor's degree in related discipline such as Computer Science, Business, Mathematics, Statistics, Science or Engineering, and 4-5 years of related experience, preferably 2-3 years in a supervisory capacity; or an equivalent combination of education and experience. Master's degree preferred
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled