Brian I. Email & Phone Number

Seattle, Washington, United States

Manage clinical study/project implementation, leading team members through CRF, lab, and other data collection processes, reporting and analysis requirements, study/project documentation and training. Establish timelines and milestones, monitors and communicates ongoing status and progress.Subject matter expert for data management issues between study team members and external domestic and international research sites for assigned studies, including conducting site trainings, development of study specific procedures and other protocol-related data management materials.Assist in the development of study protocols from draft protocol to optimize collection of accurate and high-quality data.Design, develop, maintain and document data collection instruments for assigned studies, including development of overall database, forms, edit checks and data reporting tools.Monitor study data for protocol compliance to ensure the quality and completeness of the data submitted by implementing quality control procedures.Prepare status reports and direct reporting of study metrics to study/project sponsors, team, SCHARP management, and stakeholders.Coordinates Safety/Study Monitoring Committees or Data and Safety Monitoring Board review process.Closes studies/projects ensuring that all project work has been fully completed, documented and stored.Create and maintain the Trial Master File (TMF) and ensure that SCHARP meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP).Contribute to the ongoing development of SCHARP procedures and practices by participating in committees and working groups with an aim at the development and maintenance of standardization tools and training materials.Act as a SCHARP-wide resource providing guidance on best practices and provides subject matter expertise and input on network-specific questions and mentor and/or supervise Clinical Data Coordinators and/or Clinical Data Managers I or II.

Seattle, Washington, United States

Proven project manager and information technology leader with 20+ years of experience managing projects and IT systems in the Professional Services/Pharmaceutical/Biotechnology space. Coach, mentor and experienced manager of teams up to 15 staff, including data managers, project managers, software development teams, DevOps administrators, security analysts and system/network administrators. Organization and communication skills a plus – ranging from board of director presentations to management of small project teams. Proven track record managing 3rd party vendors to meet scope and budget objectives. Able to identify gaps within organization’s corporate infrastructure, information technology and security systems. Seamlessly manage multiple competing priorities within a team or organization and report to senior management. Highly motivated, honest and ethical.

Seattle, Washington, United States

Seattle, Washington, United States

Direct the daily operations of the Axio Information Technology systems and network infrastructure. Provide monthly Information Technology overview/summary to CEO and senior management team. Provide annual Information Technology review to Board of Directors. Identify, negotiate and purchase networking hardware and software. Perform risk-based validation of all software implemented at Axio. Perform full validation of all GxP compliant software and software used to store, manage or in the analysis of clinical study data. Define technical policies as related to all aspects of Information Technology. Author, review and approve standard operating procedures for all Information Technology system implementation, validation and network infrastructure processes. Author, review, approve and implement business continuity plan. Write departmental budgets, coordinate outside vendors and resources and design and plan major Information Technology upgrades and system implementations. Provide administrative supervision of Axio Information Technology staff. Perform System Administration tasks as needed.

Seattle, Washington, United States

Oversee and direct data management and statistical work on clinical trials for biotechnology, pharmaceutical and medical device companies. Create project proposals, negotiate project contracts, assist in bid defense and participate in client audits. Hire and manage staff. Author corporate and study-specific project related procedures. Directed effort to, design, develop and implement clinical study data collection systems, both systems developed at Axio (custom software) and commercial off-the-shelf systems. Author work instructions and train on use of electronic study data collection systems for site, clinical, Axio and sponsor personnel. Specify and implement both manual and electronic edit checks. Perform listing reviews of study data. Review medication and event coding. Review and reconcile serious adverse event data. Work with Biostatisticians to extract and merge study data with other internal and external data sources. Work with vendors, site and sponsor personnel to close and lock clinical study databases. Establish and manage budgets, supervise project teams and coordinate outside resources. Detail and report study metrics, budget and progress to management staff. Manage 3rd party vendors delivering supporting services to Axio.

Seattle, Washington, United States

Monitor and supervise the daily operations of the Axio data management staff, including; Software Development team, Data Coordinators, Project Managers and Data Technicians. Hire and train data management staff. Monitor and manage staff performance, author and deliver performance evaluations. Provide technical assistance to Project Directors, including; CRF and database design, data reconciliation, data quality procedures and implementation and use of data management software. Oversee the quality and timeliness and data storage, data delivery and custom software development efforts. Provide technical assistance and author data extraction guidelines to ensure valid extract of data, for use by statistical team or Sponsor. Author, review and approve standard operating procedures for all data management processes. Author departmental budgets, coordinate outside vendors and resources, design and plan implement training for data staff. Train site, Sponsor, clinical team and outside vendors in the use of data collection systems.

Seattle, Washington, United States

Develop and implement Molecular Microbiology Lab procedures with Dr. Xuan Qin including; lab set-up, establish lab goals and direction, interview personnel, staff allocation, assist multiple ongoing research projects, and present lab findings. Coordinate budget and procedure benchmarking for the Cystic Fibrosis research and clinical sections. Efficiently handle clinical specimens, process, and enter clinical findings in a busy hospital laboratory setting.