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Form of workJob Description
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:
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 Client 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 Client 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 Client 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 Client 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 Client guidance.
Engage and support study and CSMT project teams as deemed necessary.
Ensure delivery of data to Client departments and third-party vendors consistent with Client SOPs and forms.
Additional tasks within 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)
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:
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 Client 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 Client 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 Client 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 Client 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 Client guidance.
Engage and support study and CSMT project teams as deemed necessary.
Ensure delivery of data to Client departments and third-party vendors consistent with Client SOPs and forms.
Additional tasks within 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)
