IRT Manager


Clinical Operation, Research and Development


(Associate) IRT Manager

Starting Date
Direct Report

Clinical Supply Director

Direct Subordinates
Primary Function

Be responsible for managing all Interactive Response Technology (IRT) activities associated with I-Mab sponsored clinical studies, including its setup, validation, maintenance, enhancement and closeout.

Major Responsibilities and Duties
  • Cooperating with procurement team and clinical study team, select the right IRT vendor for the specific study in a cost-efficiency manner, also get involving in process of proposing, bidding, contracting and billing from clinical supply perspective.
  • Collaborating with project study team and IRT vendors, to interpretate the protocol into IRT language, ensuring the quotation/price reflecting right design of study, minimizing change orders as less as possible.
  • Closely working with internal cross-functional team and external partners to lead IRT setups, validations, enhancements, and study-specific operations to ensure compliance with protocol and l quality requirements.
  • Taking lead of User Acceptance Testing (UAT) prior to system officially go-live, identifies potential system bug and manages creation of test plan, as well as develops test scripts to ensure proper risk mitigation. Leads improvement opportunities related to UAT across projects/programs to improve efficiency.
  • Supporting day-to-day activities to resolve IRT-related issues with study team and IRT vendors, primarily from (but not limited to) system updates driven by protocol amendments, optimizing design, and fixing system bugs.
  • Leads and supports IRT Improvement Initiatives and manages improvement projects that impact daily operations to improve efficiency.
  • Assistants and supports the development and implementation of Standard Operation Procedures (SOP) and processes related to IRT.
  • Additional responsibilities as required and directed by direct line manager.
  • Bachelor or Master Degree in Computer Science, Business Administration, Operations Management, or similar education required.
  • 3 – 5 years with progressive experiences managing IRT systems.
  • Computer Skills: Proficient in Microsoft Office applications, EDC, IRT systems.
  • Ability to work independently and collaborate with team.
  • Strong oral and written communication skills in Chinese and English.