Hoss R.
Lead Clinical Data Manager @Duke Clinical Research Institute
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WORK HISTORY
Lead Clinical Data Manager @Duke Clinical Research Institute
Durham, NC, US
Provide day to day leadership and support to team members, and help support leadership in their role.• Manage, organize and assign causality committee clinical event classification work volume for Investigators on monthly basis. • Develop and maintain a Data Management Plan. • Plan and prioritize Data Management team work.• Monitor work quality and productivity, and ensure compliance with SOPs, and Work Instructions. • Provide standard weekly quantitative progress reports to internal & external project teams. • Track progress on deliverables and production. • Coordinate user access to data systems, including account management for external users. • Lead frequent data team meetings and assure that pertinent information is communicated to team members.• Communicate with sponsors and other sub-groups to coordinate system start-up, change control, and post production management.• Lead cross-functional communications for eCRF development, and to clarify and resolve data issues.• Maintain & manage project capacity plan, budgeting, and resourcing. • Maintain project specific metrics & updates.• Database mock-up & design based on protocol requirements.• Create test data for data validation checks and other stored procedures, and oversee user acceptance testing for query rules, dynamics and calculations. • Oversee user acceptance for data entry screens. • Develop specifications for custom reports.• Oversee testing of project specific reports.• Write project specific work instructions for data management process. • Write specifications (define logic) for data validation checks (query rules) using SQL.• Perform user acceptance testing for data systems. • Oversee the execution of quality control work instructions, and provide guidance and direction for staff in resolving findings.
ABOUT HOSS R.
I have 25 years of experience in the field of data management. I have proven ability to perform as a team leader, and to provide effective communication with clinical and operational team leaders and members. I am creative, enthusiastic, committed and detail-oriented. In an environment characterized by continual and significant changes, I have consistently demonstrated high productivity and efficiency. I possess the ability to prioritize and multi-task projects.I have experience working with multiple international mega-trials and mid-size trials, funded either by industry and/or by government. My experience has been focused on the following therapeutic areas: Cardiology, Hepatology & Liver Disease Network, Treatment Strategy, Asthma, and Adolescent Depression Network.Having a background in engineering, I have strong technical skills. I have worked on development of complex data integration and data transfer structure, and processes in a fully-automated environment. Additionally, I have worked on defining specifications, mock-up, design and management of DCRI first custom & electronic adjudication systems for one of the current research networks. My experience also extends to involvement with a multiple projects web-site, in terms of defining specifications, structure, participation in the development phase and managing the content. Data migration is another technical area where I have acquired much experience. I have data mapping experience in regard to data migration in multiplatform environments. I have led and performed project data migration in an Oracle environment, as well as web site content migration from a Standard HTML environment to a Plone content management environment.Additionally, I have developed extensive training materials and documentations for InForm system project specifics as well as custom defined web application.
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