Sr. Manager, IRT User Acceptance Testing

Bristol Myers Squibb; Princeton (NJ); On-site; USD 134,000 - 163,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) Plan

Job summary

Bristol Myers Squibb is seeking a Sr. Manager, IRT User Acceptance Testing in Princeton, NJ to lead QA and UAT activities for IRT systems supporting clinical trials.

You will manage validation across multiple projects, develop test strategies, and mentor staff to ensure regulatory compliance and on-time delivery. The role requires strong SDLC and vendor management skills, with a focus on cGMP, 21 CFR Part 11, and ICH E6 (R2) standards, and collaboration with cross-functional teams and external

Qualifications

• BA/BS in life sciences, computer science, or MIS or related field.
• 8+ years in clinical technologies validation or equivalent experience.
• Strong understanding of SDLC and regulatory requirements for trials.
• Experience with IVRS and electronic management of clinical supplies.

Responsibilities

• Develop Test Plans and Test Strategies for IRT projects.
• Mentor new hires and train on department processes.
• Educate on UAT processes and methodologies across teams.
• Develop and coordinate UAT approaches and documentation.
• Determine acceptance criteria for systems and review test deliverables.
• Maintain all executed Test Assets and related documentation.
• Ensure UAT compliance with regulatory requirements (cGMP, 21 CFR Part 11, ICH E6(R2)).
• Collaborate with study teams and vendors to deliver quality systems.

Skills

QA testing

UAT planning

SDLC knowledge

Vendor management

Project management

Regulatory compliance

Education

BA/BS Life sciences / computer science / MIS

Tools

IVRS

Test management tools

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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, complex titration and adaptive study design and validation.
• Ability to interpret and identify potential data unblinding scenarios.
• Moderate understanding of relationship 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.

Compensation Overview

Princeton - NJ - US: $134,170 - $162,586

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. 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.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefits

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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 Include

Paid Time Off

• 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 for employees 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 Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients’ lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

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. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit https://careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1605024 : Sr. Manager, IRT User Acceptance Testing