Job Overview:The IRT Project Manager is accountable for study specific Interactive Response Technology (IRT) implementation, ongoing conduct support, closeout and decommission. Provides subject matter expertise, leads study specific implementation, ensures on time delivery, and remediation of support issues.
Lead study specific IRT Implementation Teams
- Leads a cross functional team comprised of Clinical Trial Supply, Global Clinical Operations, Biostatistics, Data Management, vendors and others as needed to specify, test, implement and manage study specific IRT systems.
- Create and drive IRT related timelines and deliverables
- Conduct internal review meetings of vendor written user specification requirements and integration specifications
- Plan, facilitate and lead IRT study review meetings
- Ensure completion and approval of all IRT related documentation including specifications
- Ensures compliance with relevant regulations, i.e, GxPs, ICH E6
- Study specific primary point of contact for IRT vendor
- Provide advice and direction to IRT Implementation Team for utilization of IRT system
- Serve as subject matter expert on best practices for all aspects of IRT
- Act as a central knowledge repository regarding IRT experiences and shares lessons learned across teams
- Define and complete initial information documents used for requesting a proposed scope of work from IRT vendor
- Provide expert input on all IRT related specification requirements
- Review User Requirement Specifications and any other IRT related specifications to ensure sound implementations and configurations that will meet study specific and program needs
- Supply advice and expertise on any proposed system changes after launch
- Deliver expertise to the planning and execution of User Acceptance Testing (UAT)
- Review and approve a schedule of testing that reflects the agreed User Requirements Specifications (URS)
- Create study specific IRT Test Plan
- Create study specific IRT test scripts
- Facilitate UAT by providing support and direction to IRT Study Implementation Team, ensuring that any issues are discussed with the vendor, and that a course of action is agreed and documentation is completed appropriately
- Ensure necessary data exchange (i.e. integrations or data transfers) between IRT and other systems
- Partners with stakeholders to define instances where data exchange is needed
- Collaborates with stakeholders to determine data exchange solution
- Oversees initial and periodic testing to ensure transfers are timely, efficient and bug-free
- Provide guidance to the study team for vendor implementation of site initiated data changes
- Accountable for study specific IRT contract, budget and change orders
- Supports Global IRT Lead in managing and governing IRT processes
- Fosters collaboration among internal stakeholders including but not limited to Clinical Trial Supplies, eClinical Technology, Global Clinical Operations (Study and Site Management), Biostatistics, Data Management, Clinical Procedural Documents & Standards, Clinical Quality, Regulatory and Outsourcing
- Advises manager of project status and issues as they arise
Education/Qualifications: A degree (BSc or equivalent) in an IT, technical or life science discipline or equivalent work experience in a relevant industryExperience: Minimum 3 years experience in clinical development including 2 years experience with IRT systems used for clinical supply management and randomization
Direct experience leading the development, implementation, oversight and decommissioning of IRT systems
Direct experience writing/reviewing IRT specifications, and preparing for and conducting of User Acceptance Testing
An excellent working understanding of both Clinical Operations/Project Management and Clinical Supply Management
Leadership of IRT capabilities
Collaboration among departments in a global matrix environment
Comprehensive understanding of clinical trial processes, including knowledge of ICH-GCP regulations and 21 CFR Part 11 and the conduct of clinical studies
Strong analytical skills with a focus on process mapping and user requirement development/testing
Excellent communication and training skills
Excellent organizational and time management skills with attention to detail
Ability to work independently and as a team member in global teams
Innovation and diplomacy skills
Time management project planning and co-ordination/implementation