Children’s Oncology Group (COG), a project of Public Health Institute (PHI), is a National Cancer Institute (NCI) supported clinical trials cooperative group, and the world’s largest organization devoted exclusively to childhood and adolescent cancer research. Clinical research is conducted at more than 200 member institutions, which are leading children’s hospitals, universities, and cancer centers throughout the United States, Canada, Europe, Australia, and New Zealand. COG’s over 9,000 multi-disciplinary cancer researchers, affiliated with the network of member institutions, provide access to state-of-the-art therapies and the collective expertise of world-renowned pediatric specialists to children with cancer, regardless of where they live. Today, more than 90% of 14,000 children and adolescents diagnosed with cancer each year in the US are cared for at Children’s Oncology Group member institutions.
Reporting to the Group Statistician, the Director of Research Data Informatics sits at the intersection of statistics, database administration, software development and system integration. This position will play a key leadership role and provide the overall vision and strategy for the development, implementation, and integration of clinical trial information management systems and state-of-the-art clinical trial data analytic capabilities to ensure data integration for clinical trial and related research activities in accordance with COG’s priorities. The Director of Research Data Informatics will collaborate with functional leaders to establish the vision and define strategies for meeting determined requirements and be accountable for driving the identification, evaluation, selection, implementation and ongoing administration and improvement of systems, platforms and procedures to execute the defined strategies into long-term architecture solutions.
Essential Duties & Responsibilities
- Formulate a clear vision and provide leadership to execute and maintain COG’s research data informatics and analytics with the collaboration and input of key stakeholders including but not limited to the COG Group Chair, Group Statistician, Director of Information Technology (IT) Development, Chief Operating Officer, League Directors and Committee Leadership.
- Develop a comprehensive understanding of COG’s in-house developed and commercial data software, database architecture and internal and external integrations. Gain an understanding of the external core services that COG’s systems interface with along with the challenges and opportunities each presents to the overall informatics of the Group. External core services include but are not limited to: COG’s Biopathology Center at Nationwide Children’s Research Institute, the NCI’s Cancer Trials Support Unit (CTSU), Imaging and Radiation Oncology Core (IROC), and various academic and commercial reference laboratories.
- Demonstrate strong subject matter knowledge on latest technology innovations in the research informatics; share relevant newer concepts to key stakeholders with a view to gain efficiency through standardization and automation.
- Act as the primary advocate for the advancement of new informatics, analytics and reporting capabilities. Collaborate closely with the IT Development team to define and articulate the business requirements for needed software or database development, enhancements or integrations. Sign off on the requirements and design of all newly-developed and the enhancements of existing in-house software and integrations.
- Explore opportunities for improving clinical trials data collection, data standardization, and data commons efforts, including the opportunity to allow participating sites to submit data directly from established registries, electronic health records or data warehouses.
- Investigate the development of standardized reporting systems to integrate with COG data systems as well as interactive user-friendly interface opportunities for real-time COG Leadership use to oversee the study and operational metrics.
- Participate in COG group meetings, leadership retreats, and strategic planning sessions to understand and address the informatics needs of the Group. Attend national scientific and federal administrative meetings in order to ensure that the interests of COG’s informatics are represented.
- Serve as the point of contact and subject matter expert for interactions with pharmaceutical companies and government agencies related to questions about COG’s data systems.
- Hire or recommend the hiring of personnel and provide staff training and development, conduct performance evaluations and implement performance improvement plans, as needed, to ensure efficient and professional operational support of informatics.
- Establish and maintain an open professional environment with an emphasis on learning, accountability, flexibility, and high ethical standards; ensure effective processes are in place and that staff are empowered to complete tasks in a timely and effective manner; evaluate and provide feedback, including performance improvement plans for personnel.
- Author grant research plans to address data informatics. Develop and justify associated budgets.
- Manage special projects and perform other duties as assigned by the COG Group Statistician.
- Proven ability to collaborate with senior functional leaders to set the vision, drive innovation and facilitate the transformation to meet evolving needs and priorities.
- Demonstrates capabilities in cross-functional process assessment, problem-solving and process improvement.
- Proven personnel management strength including demonstrated ability to select, motivate, develop and retain people and promote collaborative team efforts.
- Familiarity with essential FDA and other federal regulations governing clinical trials.
- Demonstrated understanding of clinical trials (cancer trials, preferred), healthcare data, and research operations.
- 5 years of experience in working with clinical data and creating methods and workflows for aggregating data.
- Excellent written and verbal communication skills.
- Adept at connecting data sets from disparate sources.
- Familiar with managing technical resources, including systems administration, applications development, database administration, network operations and data center operations.
- Masters in mathematics, computer science, informatics, or related field required.
- Experience in electronic data capture (EDC), database design, development and implementation is highly desirable. Specific familiarity with Medidata Rave or similar clinical trial management system.
- This is a full-time (40 hours/week) position.
- To qualify for this position, applicants must be legally authorized to work in the United States.