Sr. Manager, IRT User Acceptance Testing

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Position Summary

This position is responsible for the development and implementation of the Quality Assurance (QA) and User Acceptance program for IRT systems in support of clinical trials. The incumbent will have final responsibility for all QA and Test activities for assigned projects. This will require managing validation across multiple concurrent projects.

Position Responsibilities

• Develops Test Plan and Test Strategies for all IRT projects assigned.
• Assists with development of quality assurance strategy for UAT Standards, Processes, Procedures, Methodologies, and Practices to support CSC areas of responsibility
• Act as a mentor to new hires by assisting with training on department processes and procedures.
• Educates internal and external personnel on UAT process and methodology.
• Manages the development of User Acceptance Test (UAT) approaches and documentation.
• Responsible for determining acceptance criteria of systems.
• Manages the UAT structure for developing, organizing and maintaining test cases.
• Maintain and responsible for all executed Test Assets generated by a project.
• Assist the IRT Team in developing and coordinating the UAT plan for each system.
• Reviews and approves all project Test Deliverables.
• Reviews and provides feedback on User Requirements.
• Reports on quality metrics for all projects assigned.
• Analyze vendor and internal observations on system functions and process to suggest and initiate internal and external objectives.
• Ensures sufficient infrastructure to support quality initiatives.
• May assist with the development of processes and standards.
• Collaborates and assists in management of vendor activities.
• Independently makes decisions to ensure the effective resolution of issues as they develop.
• Limited travel may be required.
• Ensure time delivery of user acceptance testing of assigned IRT systems consistent with BMS SOPs and procedures. This includes fostering collaboration and best practices with the IT QA organization.
• Ensure UAT of systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance BMS SOPs and processes.
• Engage and support study and CSMT project teams as deemed necessary.
• Additional tasks within scope of expertise and experience as assigned by the supervisor in pursuit of BMS goals.

Experience Requirements

• BA/BS Life sciences / computer science / Management Information
• Systems PLUS  8+ years clinical technologies validation experience OR equivalent. Preferred experience with IVRS and electronic management of clinical supplies distribution.
• Moderate/strong understanding of drug development process and regulatory requirements for clinical trials.
• Strong Project Management skills with the ability to manage multiple projects simultaneously.
• Strong understanding of industry technologies.
• Advanced communication and negotiation skills.
• Strong understanding of System Development Life Cycle (SDLC).
• Strong understanding of capabilities / limitations of IRT technology.
• Strong vendor management skills.
• Ability to drive multiple projects to deliver a quality system on time.
• Strong analytical skills / influencing skills.
• Strong knowledge of randomization and study drug management processes.
• Strong understanding of legislative and regulatory requirements with respect to investigational drugs and supporting computerized systems.
• Ability to evaluate the quality of complex studies such as; dynamic rand, co