Project Manager III - System Design
Cenduit LLC is the largest IRT (interactive response technology) specialist in the world with the expertise to empower study sponsors for success by implementing a completely personalized system that puts them in control of their clinical trials. Cenduit was founded in May 2007 and emerges from a robust tradition of clinical development and supply chain expertise from two world leaders, Quintiles and Thermo Fisher Scientific.
Meeting the needs of investigator sites and patients, Cenduit offers clinical supply chain intelligence and clinical operations know-how through its IRT-driven services: rapid study start-up software, patient randomization (RTSM), patient reminders, drug supply management, and eClinical integration. Cenduit has over 500 experts worldwide in the US, UK, Switzerland, India and Japan, with clinical trial experience in more than 100 countries, interacting with more than 600,000 patients at more than 32,000 sites.
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
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
8-10 years clinical research or project management experience
Experience working in IRT and in a customer service environment preferred
Why is Cenduit a great place to work? Visit The Muse to find out more!
Cenduit offers equal employment opportunities without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, national origin, age, disability, genetic information, veteran or military status and other protected class characteristics.