Remote from anywhere in the U.S. or Canada.
Responsible for IRT system initial implementation, maintenance, and closure.
Provides subject matter expertise, leads study specific implementation and integration, ensures on time delivery, and remediation of support issues.
Ensure comprehensive understanding of requirements and design to provide quality deliverables.
Organizes kick-off meeting and team meetings.
Coordinates review and sign-off of requirements and release documents.
Directs teams during development and testing for initial implementation and updates.
Deliver broad expertise to the planning, documentation, and execution of User Acceptance Testing (UAT)
Coordinates documentation and closure of issues.
Manages post-production change controls.
Facilitates database lock activities with study team, vendor, and other stakeholders. Coordinates decommissioning and archiving.
Advise the team and stakeholders, informing on the processes that will be completed to enable system implementation and updates.
About 10% travel expected
Minimum 3-5+ years of experience in IRT clinical systems. Equivalent experience in other systems such as CTMS, ePRO, EDC or an equivalent combination of education and experience to successfully perform the key responsibilities of the job may also be considered.
Strong oral and written communication skills. Experience as a project leader and presenter.
Able to work both independently and collaboratively across multiple functional areas.
Proficiency in converting complex technical and business requirements into clear test plan and test cases.
Understanding of Drug Development and Clinical Trial Processes
Understanding of Data Management Processes
In-depth knowledge of Good Clinical Practices
Understanding of Clinical Research System Development Lifecycle
Must have sound problem resolution, judgement and decision-making skills.
Ability to prioritize tasks effectively and manage multiple projects simultaneously.