IRT Manager

Department
部门

Clinical Operation, Research and Development
临床运营部,研发部

Title
职位

(Associate) IRT Manager
IRT系统(副)经理

Starting Date
任职时间
Direct Report
直线经理

Clinical Supply Director
临床供应总监

Direct Subordinates
直接下属
N/A
Primary Function
主要职能

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
主要职责和任务
  • 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.
Qualifications
资格要求
  • 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.