Clinical Operation, Research and Development
(Associate) IRT Manager
Clinical Supply Director
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.
- 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.