Manager, Interactive Response Technology

Job Description

Working with Us

Challenging. Meaningful. Life-changing. Those aren&apost 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&aposll 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

Manages IRT for multiple studies (system development, vendor oversight, change management, data provisioning). Supports UAT Services organization as required. Identifies areas of process improvement and participates or leads these initiatives.

Position Responsibilities

- Lead successful execution and on time delivery of Interactive Response Technology (IRT) and support integrations with other clinical systems (e.g., Depots, Central Lab, and EDC), such that the resultant IRTs are fit-for-purpose as defined by protocol and study operational parameters with special emphasis on adherence to BMS standards and quality principles.
- Lead IRT projects as a strategic partner and single point of accountability to partner lines for IRT protocol assessments, requirements elicitation, system deployments, and resupply.
- Work independently and assume decision making responsibilities on assigned projects. Collaborate with the IRT Leadership Team where necessary to ensure BMS standards and/or for requests by study teams that are not within these standards or best practice are addressed.
- Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team.
- Maintain vendor performance quality events in ADI log.
- Support IRT improvement initiatives and manages improvement projects that impact daily operations to improve efficiency.
- Support key department and enterprise level initiatives as the IRT representative.
- Responsible for generation an oversight of 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 seamless services; as well as, foster a collaborative relationship.
- Consult and ensure on time delivery of user acceptance testing of IRT systems consistent with BMS SOPs and procedures. This includes fostering collaboration and best practices with the IT QA organization.
- Ensure 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.
- Ensure effective system access and functionality across all countries and all user locations
- Ensure on time 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 all unblinding activities.
- Ensure eTMF compliance at the study level in accordance with group and BMS guidance.
- Engage and support study and CSMT project teams as deemed necessary.
- Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms.
- Additional tasks within scope of expertise and experience as assigned by the supervisor in pursuit of BMS goals.

Degree Requirements

Bachelor&aposs Degree

Experience Requirements

- Minimum of 5 years work experience preferably in a health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.)
- Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint

Key Competency Requirements

- Clinical Research experience
- Working knowledge of IRT
- Working knowledge of Clinical Trial Management Systems
- Working knowledge of clinical supplies
- Able to think outside of the box, have excellent communication and analytical skills to successfully deliver optimal IRT solutions across a diverse and dynamic portfolio
- Understand the nature of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards
- Exposure to working in a GMP / GCP environment and with regulatory audit teams
- Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required
- Comfortable working with a global team, partners and customers in a change agile environment
- MS Project, MS Visio, or any other requirements visualization and analysis tools)

If you come across a role that intrigues you but doesn&apost perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients&apos 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.

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 [Confidential Information] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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/

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

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