Project Manager III

    • Shanghai, China

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.

Primary Responsibilities:
System Design Role

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
  • Manage the study timelines and ensure study gets delivered before First Patient In (FPI)
  • Review scope against initial proposal and manage needed budget changes
  • Perform system quality review (SQR) with Technical Operation team after the study is programmed and demo the system to the client
  • Manage the UAT activities with the technical PM team based on the client needs
  • Manage system change requests for protocol amendments
  • 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

Client Services Role

The main purpose of this role is to manage the assigned IRT studies and programs in a way that ensures all patients get the right study drug on time and the study and data integrity are maintained from study go live to close out.

An important aspect of this role is to develop the relationship with the client while the study is ongoing in such a way that they look to Cenduit as a trusted partner.

  • Study maintenance, organise or participate in regular client meetings
  • Respond to all client requests in a timely manner, manage study and Program budgets, Change Orders (COs) as required
  • Provide regular updates to client on study related information
  • Work with APM to author data change requests based on Client's request, pre-approve data change requests as needed
  • Coordinate the implementation and review of the data changes
  • Review helpdesk tickets that get escalated from APM team
  • Take appropriate actions to resolve the tickets as quickly as possible, initiate updates to helpdesk study guides
  • Work with APM to write study user guides
  • Investigate issues and manage them through to resolution
  • 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
  • 4-6 years clinical research or project management experience
  • Experience working in IRT and in a customer service environment preferred
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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