Project manager IRT

System Design Role 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.

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