Technical Business Analyst 

• Exemplary interpersonal, communication and education skills toward facilitating the use of new software systems
• This role necessitates self-direction, motivation, organization, strict attention to detail and problem solving and decision making abilities
• Knowledge of a CTMS\CTMF
• Knowledge of clinical database study build is a plus
• Advanced knowledge of programming languages like SQL, MS Access and system integration solutions
• Advanced knowledge of systems used to support operational clinical research activities (e.g.: document management systems, laboratory management (LIMS) systems, learning management systems, etc.)
• Advanced knowledge of 21 CFR Part 11 compliant electronic signature requirements

• A minimum of five (5) years of experience working in the clinical research field of computer systems programming; operations; systems, data base or network enterprise system support (hardware or software level); or information technology management consulting.
• Experience working in a CRO or Pharmaceutical Clinical Trial environment a plus.
• Extensive experience in technical business analysis in clinical research.
• Able to facilitate internal end-user proficiency.
• Able to design and maintain efficient customer portal support and feedback channels.
• Advanced knowledge of data security and encryption.
• Able to keep up with IT advancements.
• Knowledge of relevant licensing and industry compliance regulations

• A Bachelor’s Degree with a major in computer science, electronics or management information systems and or relevant professional experience is required.
• An accreditation in management consultancy.

• Gather requirements and evaluate/ analyze various systems to support clinical research operations and related project management activities (e.g.: document management systems, laboratory management (LIMS) systems, learning management systems, etc.)
• Make recommendations to IT and leadership for purchasing various systems as noted above.
• Generate reports and visualize data for project management from various systems as noted above.
• Manage\amend Access database
• Develop and perform related document management\tracking SOPs, work practices, etc
• Develop and provide training on systems (e.g.- for implementation, updates, etc)
• Reports, analytics, visualization from systems.
• Performs system analyses on software programs, applications, and web services and makes recommendations for necessary changes or upgrades.
• Acts as the liaison with collaborators and vendors, internal departments and clinical sites to ensure system viability and user familiarity and proficiency.
• Works with staff to develop and deliver all appropriate and necessary reports.
• Works with key departments to ensure and maintain relevant efficiencies within the system.
• Assists management with identifying areas of improvement and enhancements and obtains approval for system development projects.
• Efficiently integrates new systems, programs, and applications with business operations and services.
• Analyzes and improves the performance of web-based customer portals and support services.
• Monitors product licenses and ensures compliance with IT industry regulations.
• Ensures that computer hardware remains compatible with system enhancements and updates.
• Participates in on-going continuing education courses or seminars.