Overview
Remote
On Site
Full Time
Skills
Professional Development
Mentorship
FSA
Insurance
Confluence
Training
Health Care
Biostatistics
Data Management
Research
Spectrum
Clinical Research
Google Cloud Platform
Google Cloud
Policies and Procedures
Supervision
Regulatory Compliance
Quality Control
Database
Data Quality
Management
Reporting
Statistics
Clinical Trials
Writing
Job Details
Please note VCU is not able to provide current or ongoing visa sponsorship for this position.
Benefits At a Glance
Mission: To reduce the state cancer burden for all Virginians by addressing the confluence between biological, social, and policy drivers through high-impact, cutting-edge research; person-centered care across the continuum, from prevention through survivorship; community integration; and training the next generation of community-centric researchers and healthcare professionals
Vision: To be a premier community-focused cancer center leading the nation in cancer health equity research and ensuring optimal health outcomes for all
Position Primary Purpose and General Responsibilities
The Massey Comprehensive Cancer Center (MCCC) Biostatistics Shared Resource (BSSR) seeks to hire a data management and reporting specialist to support clinical cancer research, serving as an administrative liaison of data between the Clinical Trials Office (CTO) and the BSSR. The CTO includes a wide spectrum of oncology clinical studies and trials as well as clinical cancer researchers, the clinical research office, and fellow biostatisticians. Scientists strictly follow Good Clinical Practices (Google Cloud Platform) and all current laws, regulations, guidance, policies, and procedures developed by the Institutional Review Board (IRB), Code of Federal Regulations (CFR), and all federal, state, and local regulatory entities. Responsibilities of the Data Manager may be independent or as a member of a team. They work under general supervision, resolving routine-to-complex issues independently and referring more complex issues to an upper-level manager. This individual will report to the director of the BSSR but will work closely with key personnel within the CTO, including the CTO director, to ensure database development is in compliance with Common Data Elements (CDE).
The Data Manager will involve highly collaborative interactions with MCCC staff and investigators, working alongside other staff to ensure quality control on various projects and attend core/project meetings. In addition to the responsibilities listed below, other job responsibilities may be assigned with emphasis on:
1. Data capture and management for oncology clinical trials (50%). Work with the Clinical Trials Office personnel to design and create databases for clinical studies and trials.
a. Develop and maintain REDCap databases.
2. Report generation for clinical trials (25%). Help support on-trial monitoring by planning and creating regular reports on accrual, data quality, safety and (in some cases) efficacy. Oversee development and delivery of tables and reports for ClinicalTrials.gov reporting for all trials.
a. Write, modify, maintain, and validate computer programs for project reports.
b. Review and update statistical analysis plans to ensure accuracy.
c. Run systematic reports for clinical trials.
3. Create analysis data sets for clinical and translational studies (25%). Work with biostatistical teams to organize trial and study data into analyzable formats, provide basic summaries, Tables and Figures, conduct basic biostatistical analyses (ex. correlative studies), and assist with manuscript writing and preparation.
a. Develop analysis datasets using data from electronic data capture systems and registry data systems.
Benefits At a Glance
- 28 Vacation Days, 12+ State Holidays, and 4 Days to volunteer;
- Continuing education for undergraduate and graduate tuition for a maximum of 6 credits per semester;
- Professional development opportunities encouraged and offered for employees as part of annual career development, e.g. certifications, seminars, courses, annual conferences, mentorship;
- Medical, Dental and Vision Health Benefits to meet the needs of employees and their eligible family members from the Commonwealth of Virginia as well as optional FSA;
- Participation in the Virginia Retirement System (VRS) and other retirement saving options;
- Parental and Caregiver Leave, Short Term Disability (STD), Disability Insurance, Voluntary Long Term Care Insurance, and Employee Assistance Program.
Mission: To reduce the state cancer burden for all Virginians by addressing the confluence between biological, social, and policy drivers through high-impact, cutting-edge research; person-centered care across the continuum, from prevention through survivorship; community integration; and training the next generation of community-centric researchers and healthcare professionals
Vision: To be a premier community-focused cancer center leading the nation in cancer health equity research and ensuring optimal health outcomes for all
Position Primary Purpose and General Responsibilities
The Massey Comprehensive Cancer Center (MCCC) Biostatistics Shared Resource (BSSR) seeks to hire a data management and reporting specialist to support clinical cancer research, serving as an administrative liaison of data between the Clinical Trials Office (CTO) and the BSSR. The CTO includes a wide spectrum of oncology clinical studies and trials as well as clinical cancer researchers, the clinical research office, and fellow biostatisticians. Scientists strictly follow Good Clinical Practices (Google Cloud Platform) and all current laws, regulations, guidance, policies, and procedures developed by the Institutional Review Board (IRB), Code of Federal Regulations (CFR), and all federal, state, and local regulatory entities. Responsibilities of the Data Manager may be independent or as a member of a team. They work under general supervision, resolving routine-to-complex issues independently and referring more complex issues to an upper-level manager. This individual will report to the director of the BSSR but will work closely with key personnel within the CTO, including the CTO director, to ensure database development is in compliance with Common Data Elements (CDE).
The Data Manager will involve highly collaborative interactions with MCCC staff and investigators, working alongside other staff to ensure quality control on various projects and attend core/project meetings. In addition to the responsibilities listed below, other job responsibilities may be assigned with emphasis on:
1. Data capture and management for oncology clinical trials (50%). Work with the Clinical Trials Office personnel to design and create databases for clinical studies and trials.
a. Develop and maintain REDCap databases.
2. Report generation for clinical trials (25%). Help support on-trial monitoring by planning and creating regular reports on accrual, data quality, safety and (in some cases) efficacy. Oversee development and delivery of tables and reports for ClinicalTrials.gov reporting for all trials.
a. Write, modify, maintain, and validate computer programs for project reports.
b. Review and update statistical analysis plans to ensure accuracy.
c. Run systematic reports for clinical trials.
3. Create analysis data sets for clinical and translational studies (25%). Work with biostatistical teams to organize trial and study data into analyzable formats, provide basic summaries, Tables and Figures, conduct basic biostatistical analyses (ex. correlative studies), and assist with manuscript writing and preparation.
a. Develop analysis datasets using data from electronic data capture systems and registry data systems.
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