D05 - SUPPLY CHAIN AND LOGISTICS / PURCHASING GEN/MULTI - Business Associate

IRT Business Associate

This is a remote role working from Monday to Friday during business hours. The position involves managing IRT for multiple studies, including system development, vendor oversight, change management, and data provisioning. It also supports the UAT Services organization as required. The role identifies areas of process improvement and participates or leads these initiatives.

Responsibilities include:

• Leading successful execution and on-time delivery of Interactive Response Technology (IRT) and support integrations with other clinical systems.
• Leading IRT projects as a strategic partner and single point of accountability.
• Working independently and assuming decision-making responsibilities on assigned projects.
• Collaborating with the IRT Leadership Team where necessary.
• Maintaining vendor performance quality events in the ADI log.
• Supporting IRT improvement initiatives and managing improvement projects that impact daily operations.
• Supporting key department and enterprise-level initiatives as the IRT representative.
• Generating and overseeing patient and container randomization schedules.
• Participating in IRT vendor relationships and oversight.
• Consulting and ensuring on-time delivery of user acceptance testing of IRT systems.
• Ensuring systems and associated documentation are compliant with all regulatory requirements.
• Ensuring effective system access and functionality across all countries and all user locations.
• Ensuring on-time development of IRT data transfers with vendors and/or third-party vendors.
• Acting as the primary contact for assigned studies for the cross-functional study team and vendor during IRT Maintenance.
• Providing timely responses to all randomization/IRT issues that arise during the IRT lifecycle.
• Supporting all unblinding activities.
• Ensuring eTMF compliance at the study level in accordance with group and Client guidance.
• Engaging and supporting study and CSMT project teams as deemed necessary.
• Ensuring delivery of data to Client departments and third-party vendors consistent with Client SOPs and forms.
• Additional tasks within the scope of expertise and experience as assigned by the supervisor in pursuit of Client goals.

Education Required: Bachelor's Degree

Experience Required: Minimum of 1 year 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.