Sr. Manager, IRT User Acceptance Testing

About the role

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, managing validation across multiple concurrent projects.

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.
• Acts 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.
• Maintains and is responsible for all executed Test Assets generated by a project.
• Assists 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.
• Analyzes vendor and internal observations on system functions and processes 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.
• Ensures timely delivery of user acceptance testing of assigned IRT systems consistent with BMS SOPs and procedures, including fostering collaboration and best practices with the IT QA organization.
• Ensures 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 with BMS SOPs and processes.
• Engages and supports study and CSMT project teams as deemed necessary.
• Performs additional tasks within scope of expertise and experience as assigned by the supervisor in pursuit of BMS goals.

Requirements

• BA/BS in Life Sciences, Computer Science, or Management Information Systems plus 8+ years of clinical technologies validation experience or equivalent.
• Preferred experience with IVRS and electronic management of clinical supplies distribution.
• Moderate/strong understanding of the 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 and 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 randomization, complex titration, and adaptive study design and validation.
• Ability to interpret and identify potential data unblinding scenarios.
• Moderate understanding of relational database practices.
• Team and individual leadership.
• Demonstrated broad computer program literacy including Word and Excel.
• Strong problem-solving skills.
• Creative thinking.
• Strong collaboration skills.
• Maintains optimism and composure in times of change, uncertainty, or stress.

Pay

The starting compensation range for this full-time role in Princeton, NJ, US is $134,170 - $162,586. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits:
  • Paid Time Off for US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio employees).
  • Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Based on eligibility, additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year’s Day.

Schedule

This role follows an occupancy structure that determines work location:

• Site-essential roles: Require 100% of shifts onsite at your assigned facility.
• Site-by-design roles: May be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
• Field-based and remote-by-design roles: Require the ability to physically travel to visit customers, patients, or business partners and attend meetings on behalf of BMS as directed.