System Design Project Manager
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.
· 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
Skills & Competencies
· Strong customer service ethic, always providing excellent service to both internal and external ‘clients’.
· Established acumen in working with external clients.
· Accountable to perform tasks on-time and with high quality.
· Established IRT technical aptitude (consultative-level for System Design role)
· Excellent written and verbal communication skills
· Strong team player with ability to work independently
· Solid organizational skills including attention to detail and multi-tasking skills
· Good problem solving and analytical skills
· Strong IT skills and working knowledge of Microsoft Office
Education & Experience
· Bachelor's degree or equivalent combination of education, training and experience
· 4+ years clinical research or project management experience
· Experience working in IRT and in a customer service environment preferred
· This role will require extensive use of the keyboard and therefore repetitive motion of the fingers and will involve sitting for extended periods of time.
· Travel up to 20% might be required
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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