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

IRT Business Associate
This is a Remote Role
Work Schedule: Mon - Fri, Business Hours

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.

Responsibilities:

1. 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), ensuring adherence to Client standards and quality principles.
2. Lead IRT projects as a strategic partner and single point of accountability for IRT protocol assessments, requirements elicitation, system deployments, and resupply.
3. Work independently and assume decision-making responsibilities on assigned projects. Collaborate with the IRT Leadership Team to address requests that are not within Client standards or best practices.
4. Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team.
5. Maintain vendor performance quality events in ADI log.
6. Support IRT improvement initiatives and manage improvement projects that impact daily operations to improve efficiency.
7. Support key department and enterprise level initiatives as the IRT representative.
8. Responsible for generation and oversight of patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements.
9. Distribute patient randomization and container schedules to Clinical Supply Operations and IRT vendors.
10. Participate in IRT vendor relationships and oversight to ensure delivery of IRT systems and seamless services.
11. Consult and ensure on-time delivery of user acceptance testing of IRT systems consistent with Client SOPs and procedures.
12. 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 with Client SOPs and processes.
13. Ensure effective system access and functionality across all countries and user locations.
14. Ensure on-time development of IRT data transfers with vendors and/or third-party vendors.
15. During IRT Maintenance act as the primary contact for assigned studies for the cross-functional study team and vendor.
16. Support all unblinding activities.
17. Ensure eTMF compliance at the study level in accordance with group and Client guidance.
18. Engage and support study and CSMT project teams as deemed necessary.
19. Ensure delivery of data to Client departments and third-party vendors consistent with Client SOPs and forms.
20. 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:

1. Minimum of 1 year work experience preferably in a health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.).
2. Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint.
3. Clinical Research experience.
4. Working knowledge of IRT.
5. Working knowledge of Clinical Trial Management Systems.
6. Working knowledge of clinical supplies.
7. Able to think outside of the box, with excellent communication and analytical skills to successfully deliver optimal IRT solutions.
8. Understand the nature of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards.
9. Exposure to working in a GMP/GCP environment and with regulatory audit teams.
10. Possess excellent English language written and verbal communication, interpersonal, collaboration, and business partnership capabilities.
11. Comfortable working with a global team, partners, and customers in a change agile environment.
12. MS Project, MS Visio, or other requirements visualization and analysis tools.