- 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 ( 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.

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