BryceTech

Compliance

• Serve as technical SME for CDISC SEND and SENDIG-AR (2019)
• Develop validation criteria, business rules, and quality control procedures for DCC ingestion of SEND datasets
• Support design and implementation of DCC data architecture and metadata governance frameworks
• Establish data acceptance and rejection criteria aligned with regulatory expectations
• Contribute to DCC end user interface testing and acceptance criteria
• Assist in developing end user training and implementation plans
• Ensure alignment with Animal Rule regulatory requirements (21 CFR 314.600 and 601.90)
• Assist other contractors by translating regulatory requirements into operational data standards specifications
• Perform quality control of dataset packages
• Integrate knowledge of nonclinical study conduct to assure correct dataset output
• Knowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for dataset packages
• Communicate findings to team members and management
• Obtain proficiency with DNCD quality control workflows to include regulatory dataset [e.g. SEND] review, study report QC, and other reviews, as required
• Adhere to and/or assist in establishment/refinement of DNCD SOPs and business practice documents related to QC efforts
• Learn data audit practices with possibility to assist in remote and/or on-site data audits of BARDA contracted research
• Provide technical expertise to individual advanced research and development (ARD) and/or nonclinical project coordination teams (PCTs)
• Act as the primary data management contact for BARDA ARD/nonclinical PCTs supporting contracts issued to CHEM, RADNUC, and BIOLOGICAL network contract research laboratories (CROs)
• Coordinate with PCTs to determine intended use for data derived from contract(s) and establish data management plans intended to ensure data are fit for purpose
• Coordinate with PCTs to ensure data management plans are included within contract management plans and quality assurance project plans established by CRO contractors
• Develop strong PCT relationships that are driven by consistent study data analytic and management services in terms of quality and timeliness
• Advise CRO contractors on data delivery and format requirements
• Receive and review raw data from CRO contractors for completeness and quality according to established quality control standards
• Coordinate with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs

Regulatory Data Technical Advisor

Analyst

• Deliver policy, technical, and processes improvements to government space technology research and development (R&D) and demonstration programs
• Support NASA’s Small Spacecraft Technology (SST) and Flight Opportunities (FO) Programs
• Work with the SST/FO Program Executive and other program personnel
• Provide recommendations to tailor NASA R&D program and project management requirements to reduce time to flight with an appropriate risk profile
• Coordinate with Senior NASA personnel at centers and headquarters to build consensus on tailored requirements
• Systematically identify, recommend, and execute improvements to program policies and processes
• Document program processes and policies
• Support strategy, management, and integration operations

Senior Space Technology Policy Analyst and Engineer

Business Analyst

• Manage the integration and distribution of data for the Small Spacecraft Technology (SST) Program
• Provide information management support for the SST Program
• Develop and maintain SST’s systems that store and organize data
• Oversee, organize, store, and analyze programmatic and technical data and data products
• Share data to external stakeholders to support communication of program achievements, challenges, and lessons learned
• Administer weekly SST meetings to solicit, update, and correct program data
• Track incoming proposals and ensure that data is properly recorded in a database
• Provide technical writing and Section 508 compliance support
• Assess database performance and recommend changes and enhancements
• Resolve data conflicts for naming conventions, data privacy, and ownership
• Identify, define, and assess specifications and structures for database management systems
• Develop and implement policies related to data security, integrity, and access
• Draft training documentation and guidelines for analysts and end users
• Maintain knowledge of trends in database management systems and related technology

Regulatory Data Technical Advisor

Senior Space Technology Policy Analyst and Engineer

Program Support and Data Management Analyst