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Job Title/Role: Sr. Support Manager, Interactive Response Technology

Department Name/Functional Area: Global Clinical Supply Chain > Clinical Supply Chain Technologies > IRT

Location: Office based.

Position Summary

• This position supports multiple IRT studies (system development, study management, change management, audits and data provisioning). Supports UAT Services organization as required. Identifies areas of process improvement and participates or leads these initiatives.

Duties/Responsibilities

• Lead successful maintenance support and projects to ensure execution and on time delivery of Interactive Response Technology (IRT) changes, data 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.
• Works independently and assume support role responsibilities on assigned projects. Collaborate with the IRT 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.
• 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.
• Maintain vendor performance quality events in ADI log.
• Act as off hours audit/inspection support contact as needed to support rest of world.
• Responsible for generation and 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 P&L and IRT vendors.
• Manage special project implementation by identifying project needs, tracking, implementation, and reporting to a central project team.
• Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team.
• Support IRT improvement initiatives and manages improvement projects that impact daily operations to improve efficiency.
• Support key department and enterprise level initiatives as part of the IRT representative.
• Ensure on time delivery of maintenance support and may be involved in user acceptance testing of IRT systems per BMS SOPs and procedures, write or review User Acceptance Test Plan and causes to ensure thorough testing of high –risked areas and new functionality documented in the user requirements.

• 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.
• Complete all assigned training by due date
• Support unblinding activities as needed.
• Ensure on time development of IRT data transfers with vendors and/or third-party vendors.
• 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.

Reporting Relationship

• This position reports to the Associate Director, Interactive Response Technology (IRT).

Qualifications

• Minimum bachelor’s degree
• Minimum of 3 to 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.
• 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’t 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’ 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.

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