System Design Role
The main purpose of this role is to write the requirements of the assigned IRT studies and
manage the implementation in a way that ensures all patients get treated with the right
study drug as per the Sponsor’s study protocol. This is a highly consultative position in
which the PM needs to utilize his/her Cenduit IRT knowledge to ensure a successful system
build.
Requirements (40%)
• Analyse the protocol and discuss the system needs with the client
• Consult the client in the best way to setup an IRT system for their study
• Author the user requirement documents and review with the client study team and
• internal teams
Project Management (20%)
• Manage the study timelines and ensure study gets delivered before First Patient In
• (FPI)
• Review scope against initial proposal and manage needed budget changes
• Check progress of all deliverables and ensure internal teams get support as needed
• Perform system quality review (SQR) with Technical Operation team after the study
• is programmed and demo the system to the client
User Acceptance Testing (20%)
• Perform internal user acceptance testing with the Technical Operations team and the
• technical PM team after study is validated
• Manage the UAT activities with the technical PM team based on the client needs
• Actively support client and clarify client’s questions during the UAT
Other tasks (20%)
• Take leadership on study programs or client accounts to define standards, lessons
• learned, support sales and be part of SME teams
• Manage system change requests for protocol amendments
• Provide detailed handover training of the study and system to the Client Services PM
• Provide peer-level training, mentoring of new hires and Jr. PM Staff, and give formal
• technical training sessions. May participate in Investigator meetings, bid defences,
• quarterly business reviews with clients; and support both client and qualification
• audits.
Other related duties as required by business need
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com