Clinical IRT Business Associate
2 weeks ago
TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our client, a leading pharmaceutical company is hiring a Clinical IRT Business Associate on a contract basis. Candidate MUST be located on the east coast. MUST have work experience in a health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.). MUST have Clinical Research experience, working knowledge of IRT, working knowledge of Clinical Trial Management Systems and working knowledge of clinical supplies.
Pay: $43-45/hour W2
Required Skills:
• 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
• Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint
• 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
• 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
• 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
• 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
• 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
• Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6
• 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
• Provide timely response to all randomization/IRT issues (including data integrations and delivery) that arise during IRT lifecycle and ensure they are resolved
• Ensure eTMF compliance at the study
• Bachelor's Degree required
79390
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