Manager, Interactive Response Technology (IRT)

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Roles and Responsibilities:

• Lead Interactive Response Technology (IRT) development and implementation by interacting with statisticians, clinical staff, Trial Supply Management, and IRT vendors with special emphasis on adherence to BMS standards and quality principles. ​

• Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team.​

• Generate patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements. Distribute patient randomization and container schedules as appropriate to Clinical Supply Operations and IRT vendors.​

• Participate in IRT vendor relationships and oversight to ensure delivery of IRT systems and services and to foster a collaborative relationship.​

• Support user acceptance testing of IRT systems ​

• Ensure development of IRT data transfers with vendors and/or third party vendors. ​

• During IRT Maintenance act as the primary contact for assigned studies for the cross-functional study team and vendor. Additionally, provide timely response to all randomization/IRT issues (including data integrations and delivery) that arise during IRT lifecycle and ensure they are resolved. ​

• Support unblinding activities.​

• Ensure eTMF compliance at the study level in accordance with group and BMS guidance.​

• Participate in the IRT subject matter expert (SME) program. ​

• Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms. Including but not limited to SAS data sets from IRT vendors or internal processes to Global Bioanalytical Services (GBS).​

• Additional tasks within scope of expertise and experience as assigned by the supervisor in pursuit of BMS goals.

Requirements:

• Minimum of 5 years IRT project management experience​

• BA/BS life science or information technology preferred ​

• Moderate/strong understanding of drug development process and regulatory requirements for clinical trials.​

• Strong project management skills such as; managing timelines while ensuring quality.​

• Strong understanding of System Development Life Cycle (SDLC).​

• Strong knowledge of randomization and study drug management processes.​

• Strong knowledge of clinical protocol analysis and its application including clinical study processes.​

• Demonstrated broad computer program literacy including Microsoft Office​

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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