IRT Specialist

JOB TITLE: IRT Specialist

LOCATION: Canada or the US

REPORTS TO: Sr. Manager, Clinical Data Management

DEPARTMENT: Data Sciences-Data Management

JOB SUMMARY:

Responsible for leading, planning and the execution of all Interactive Response Technology (IRT) Data Management activities scoped within Alimentiv’s Electronic Data Capture for assigned projects. By taking a leadership role in IRT activities, ensures a focus on data integrity, validity, reliability in accordance with standard processes, sponsor guidelines, industry best practices and regulatory standards. Act as a Subject Matter Expert within the department, supporting and providing guidance to the Data Management Team on all IRT deliverables throughout the lifecycle of assigned studies, by acting as the owner and leading the delivery of the development and continuous improvement of process initiatives through cross-functional collaboration.

ROLE & RESPONSIBILITIES:

Role and Responsibilities:

Project Support

• Serve as the IRT Subject Matter Expert, responsible for driving all related deliverables and for overseeing all day-to-day IRT activities from Study Start-Up through final Database Lock, including, but not limited to:
  • • Collaborates with study team during Study Start-Up to understand requirements for IRT technologies
    • Creation and maintenance of the IRT Specifications
    • In collaboration with the assigned Lead Clinical Data Manager, assist in the design and development of the Case Report Forms for any IRT data collection
    • In collaboration with the assigned Lead Clinical Data Manager, define and assist in testing Edit Checks related to IRT
    • In collaboration with the assigned Lead Clinical Data Manager, create test cases for the purpose of database validation for both Randomization and/or Inventory/Dispensing Modules
    • In collaboration with the assigned Lead Clinical Data Manager, Database Programmer, and Study Team, perform database validation for both Randomization and/or Inventory/Dispensing Modules
    • Monitor the IP supply levels within EDC and manage shipment requests, and/or escalate, as necessary.
      
• Participate/lead Internal/Sponsor Meetings relating to any IRT points of discussion, as required, working directly with the assigned Data Management, Database Programming, Statistician and Project Management Teams
• Ensure approved study documentation pertaining to IRT is maintained and properly stored in the trial master files
• Act as a point of escalation to any IRT related issues and queries
• Provide recommendations and guidance, applying strong expertise during the set-up, amendment and optimization of drug supply related IRT functionalities with a focus on strong collaboration
• Provide coaching and support to the planning team on any IRT-related topics (randomization, system interfaces and functionality, utilization of data from IRT in demand and supply planning, unblinding practices, etc.)
• Provides support to study teams to resolve IRT issues during the conduct of the study
• Work closely with the assigned Data Management Team in specifying the appropriate Randomization and/or Inventory/Dispensing within EDC
• Work closely with the assigned Database Programming Team in building the appropriate Randomization and/or Inventory/Dispensing within EDC
• Work closely with the assigned SAS and Statistical Programming Team in the creation of the applicable reports and metrics
• Work closely with the assigned Statistician and Sponsor to determine Randomization requirements
• Working closely with the assigned Project Management Team in the management of the Inventory and Dispensing Module within the EDC during the conduct of the study
• Independently make decisions for questions contained to their assigned project(s)
• Escalate concepts to the Manager that may impact or benefit the rest of the department or other studies

Department Support:

• Contribute to the continuous improvement of CDM and the wider organization through information sharing, training, and education
• Promote and be an advocate of DM internally and externally
• Lead the development, review and implementation of IRT processes, policies, SOPs/WIs, and associated documents affecting CDM
• Lead the development of new concepts, technologies, and products to meet emerging customer needs
• May participate in and/or lead CDM and cross-functional working groups
• Owner and supporter of IRT-related metrics
• Role may support other specialized service offerings, as applicable

QUALIFICATIONS:

Applicants should have a minimum of a college diploma/degree 7-9 years of related experience. The successful candidate must exhibit the following skills: Solid understanding of clinical trial design, the development of randomization schedules, IP supply labelling/re-labelling, packaging and distribution processes, IP supply forecasting, and re-supply strategy; management of unblinded study data. In depth hands-on knowledge/experience of IRT Systems and data management.

WORKING CONDITIONS:

Office/home-based

#LI-Remote