Project Manager III

Cenduit provides interactive response technology (IRT) - driven services for clinical trials around the world. Cenduit was founded in May 2007 and emerges from a robust tradition of clinical development and clinical supply chain expertise from two world leaders, Quintiles and Thermo Fisher Scientific. Cenduit's Software as a Service (SaaS) IRT solutions deliver optimized clinical supply chain management and facilitate precise control over patient randomization and drug administration to enable more efficient, compliant trials. With expert personnel located across the globe, Cenduit's unprecedented level of support currently covers more than 32,000 sites in more than 100 countries.

Overview:
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 Project Manager needs to utilize their Cenduit IRT knowledge to ensure a successful system build.
Primary Responsibilities:

  • Analyze the protocol and discuss the system needs with the client
  • Consult with 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 and internal teams
  • 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
  • Perform internal user acceptance testing with the Technical Operations team and the technical PM team after study is validated
  • Manage the User Acceptance Testing activities with the technical PM team based on the client needs
  • Actively support client and clarify client's questions during the UAT
  • Manage system change requests for protocol amendments
  • Provide detailed handover training of the study and system to the Client Services PM
  • Conduct training at investigator/monitor meetings if needed
  • Attend Investigator meetings, client audits, and possibly bid defenses
  • May train peers, mentor new hires (PM I and junior), and additional opportunities to train in area of expertise
  • First level of escalation
  • Other related duties as required by business need
Skills:
  • 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 and growing IRT technical aptitude (consultative-level for System Design role)
  • Proficient in routine PM work
  • 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
Education and Experience:
  • Bachelor's degree or equivalent combination of education, training and experience
  • Minimum of 2+ years clinical research or project management experience

Travel up to 20%.

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.


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