■The Role & Department
The Japan Clinical Trial Manager (JCTM) is responsible for trial management in Japan while performing Clinical Trial Manager (CTM) tasks in alignment with Global Trial Lead (GTL) and CTM.
JCTM carries accountability for the successful trial execution in Japan ensuring achievement of key milestones in alignment with goals set by Clinical Trial Team (CTT) and Japan Compound Development Team (J-CDT).

■Key responsibilities include:
In addition to CTM tasks in alignment with GTL and CTM, JCTM has following responsibilities for Japan.

■Trial Planning
•Work in collaboration with JOL to assess CRO Task Orders (TOs) in assigned trials, ensuring that the outsourcing scope and costs for Japan are appropriate and aligned with trial requirements
•Set the target timeline, target number of patients, and required number of sites in Japan together with JOL and GTL, JCDT members, CRO, and other related stakeholders
•Review patient recruitment plans for Japan provided by CRO and align with JOL and other relevant stakeholders
•Collaborate with JOL, CTT and other relevant stakeholders to ensure that required actions based on Drugs used in the Clinical Trial (DUCT) are completed
•Develop Country level ICF, if applicable
•Review Japanese translation of IMP labels

■Site Selection and Management
•Coordinate cross-functional discussions to develop and prioritize site candidate lists aligned with trial strategy and Japan-specific considerations
•Drive site feasibility and selection in collaboration with CROs
•Involve in optimizing site costs in Japan

■Trial Execution and Monitoring
•Build and maintain investigator engagement at trial level to support successful trial execution and delivery.
•Ensure achievement of key milestones (CTN submission, FPI, LPI, etc.) in Japan
•Collaborate across relevant functions to proactively resolve operational challenges within assigned trials and ensure smooth trial progression.
•Update the information in local clinical trial registry (i.e. jRCT), if applicable

■Department:
•Participate in preparation for and response to PMDA Inspection as a representative of JCO, if applicable
•Work in collaboration with Process Compliance Lead (PCL) to continuously optimize ways of working related to CRO collaboration in Japan
•Contribute to department related activities, the overall department strategy and improvement initiatives/activities including Japan R&D and Clinical Trial Operations cross functional activities.
•Participate in external initiatives/task force teams such as EFPIA and JPMA and bring experience and knowledge to the relevant stakeholders, if applicable.

The Employee shall also render such other related services and duties as may be assigned from time to time by supervisor.