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 their Cenduit IRT knowledge to ensure a successful system build.
Requirements
* Analyse the protocol and discuss the system needs with the client
* Consult the client on the best way to set up an IRT system for their study
* Author the user requirement documents and review with the client study team and internal teams
Project Management
* Manage the study timelines and ensure the 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
* 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 and related 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 defenses, quarterly business reviews with clients; and support both client and qualification audits.
* Other related duties as required by business need
Our Ideal Candidate Will Have
* Bachelor's degree or equivalent combination of education, training and experience
* Several years clinical research or project management experience
* Experience working in IRT and in a customer service environment
* 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
* Travel up to 20% might be required
Equality, Diversity, and Inclusion Statement
IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential.
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