Opening
Full Time 40 hours Grade 052 SMH Hematology/Oncology
Schedule
8 AM-4:30 PM
Responsibilities
GENERAL PURPOSE:
The TCT Data Manager oversees the implementation, coordination, and evaluation of all data aspects of the Blood & Marrow Transplant and Cellular Therapy (TCT) Program to meet overall program goals and objectives under the direction of the TCT Program Administrator and with the guidance of the Quality Manager (QM). The TCT Data Manager serves as the data/analytic subject matter expert for the CIBMTR and NMDP database registries. Effectively facilitates appropriate data management with timely and accurate reporting data outcomes, accurate outcome initiatives, benchmarking, and providing immediate feedback for assigned quality initiatives. Reviews patient medical records and determines patient disease status and clinical features according to CIBMTR guidelines. Must be able to independently interpret and extract various clinical data to ensure accurate data entry. Performs audit of documentation to ensure compliance with data evaluation and entry standards.
Develops complex reports/analyses and communicates the results in a comprehensive, accurate, and understandable format. Assists in designing, developing, and programming systems needed to meet optimum data presentation goals. Supports the TCT program by collecting and reporting programmatic, quality, and performance improvement data required by all agencies and regulatory entities. The TCT Data Manager supports quantitative clinical, financial, operational, and administrative data analysis and organization. The Data Manager supports quality assurance, performance measures, process improvement plans, strategic planning, analysis & projects.
Responsible for oversight of BMT non-therapeutic clinical trials, including patient registration, data evaluation and entry, and maintenance of clinical databases. Accountable for providing accurate clinical and program data to senior leadership, the Center of Excellence surveys, and survival statistics analysis presentations.
SPECIFIC RESPONSIBILITIES:
Under general direction within policy guidelines and protocols:
- Data management, collection, scanning, review, querying, updating, filing, and reporting of this data. Collects data by the use of questionnaires, interviews, reports and searches of existing journals, etc.
- Acts as liaison with CIBMTR to provide data clarifications, to review study protocols, to ensure thorough understanding and communication, to respond to questions that arise during the study, to communicate and document adverse events as advised by the Principal Investigator and Sub Investigators, and to ensure case report forms are complete, accurate and available for review. Maintains accurate and up-to-date study subject documents.
- Serves as the data/analytic subject matter expert for the CIBMTR and NMDP database registries.
- Reviews patient medical records and determines patient disease status and clinical features according to CIBMTR guidelines. Investigates additional resources including working with the provider and identifies educational opportunities to develop enhanced understanding of disease, co-morbid conditions, or other areas. Must be able to independently interpret and extract various clinical data to ensure accurate data entry.
- Performs audit of documentation to ensure compliance with data evaluation and entry standards.
- Communicates with sponsor to clarify data queries.
Works with the quality program to report programmatic data.
- Implements strategic quality and data-related goals for the department.
- Performs ongoing quality assurance procedures, in order to ensure database integrity and that any data errors are identified quickly and corrected.
- Prepares for, participates in and serves as liaison for scheduled monitoring visits and audits conducted by the BMT Program and external agencies.
- Maintains records and conducts correspondence with a variety of agencies and officials that provide a source of information.
- Interact with external organizations including Foundation for the Accreditation of Cellular Therapy (FACT), Center for International Blood and Marrow Transplant Research (CIBMTR), National Marrow Donor Program (NMDP), Primary Immunodeficiency Treatment Consortium (PIDTC), iMetadata Rave.
- Oversee audits as appropriate, creating, maintaining, and updating corrective action plans as needed.
May perform a large number of computer search strategies.
- Prepares reports and recommendations based upon analysis of information gathered.
- Reviews retrieved information for pertinence to the project.
- Creates reports for the BMT program and initiates quality reports to deliver to the BMT Quality Program.
Meets with project participants to help formulate project goals and determine protocols and information gathering methods.
- May assist in design, development and programming of systems needed to meet optimum data presentation goals. Assists with data analysis and preparation of materials on request.
Prepares and collates patient study information, status reports and updates as necessary for reporting on progress of patients undergoing Cellular Therapy in order to accomplish a timely completion.
- Collaborates with study physicians, and BMT staff in all phases of data collection for patients receiving Cellular Therapy. Disseminates information to team members, and external agencies including the Center for International Blood and Marrow Transplant Research (CIBMTR). Develops, documents and implements data management processes and ensures compliance with all applicable regulatory and departmental SOPs, regulations and guidelines.
- Collects clinical data during all phases of care, completes required report forms.
- Reviews and collects patient data for team projects.
- Assists with data collection for long-term projects.
- Maintain REDCap and Stem Soft databases as appropriate for BMT data
Reviews work of Information Analyst I or others performing similar work, and supervises clerical staff and field work aides.
REQUIREMENTS:
- Bachelor's degree with major course work in social or technical field and some graduate level course work in that field (or library science or information science)
- 1-2 years’ experience in the analysis and dissemination of information
- or an equivalent combination of education and experience.
- Knowledge of programming and statistical programming packages would be helpful.
- Background in biology or clinical setting recommended
NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.
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How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range
Pay Range: $ 20.00 - $ 38.46 Hourly
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.