Senior Manager, Clinical Trial Manager

The Sr. Manager, JCTM is accountable for the end-to-end delivery of a single clinical trial from strategy outline through to CSR by leading cross-functional trial specific Clinical Trial Team (CTT) to deliver clinical trials including managing the trial budget if assigned to a trial as Global Clinical Trial Manager (GCTM).
As Sr. Manager, JCTM, the employee represents Japan Development Operations (JDO) in one or more Japan Compound Teams (J-CoT) and contributes to the compound development strategy in Japan.

Responsibilities/tasks as CTM
Trial Planning and Oversight
• Set target timeline, target number of patients, and required number of sites in Japan together with GCTM, JCoT members, CRO, and other related stakeholders

• Review Task Orders with CROs for Japan
• Involve in optimizing site costs in Japan as needed
• Develop operational plans, manuals and charters for the trial
• Review protocol and protocol amendments
• Coordinate development of Trial Oversight Plan
• Review Investigator's Brochure (IB) from DevOps perspective
• Review Clinical Trial Application (CTA) submission package
• Review Regulatory Green Light (RGL) packages in accordance with QDOC-08903
• Review Development Safety Update Report (DSUR)
• Develop Global Master ICF
• Follow up on Trial Oversight identified findings during Oversight until closure

Site Selection and Management
• Drive site selection in collaboration with Start-up
• Review and approve selected sites in Japan
• Review/approve SSV summary
• Coordinate review of CRO country-specific informed consent forms (ICFs) with internal
stakeholders
• Coordinate translation/back translation process of ICFs
Vendor Management and Oversight
• Oversee vendor management across vendors (does not include budget/change orders)
• Approve key CRO staff e.g., Clinical leads, or Trial specific CRA (not including CRAs part
of the partnership dedicated model which is managed via Oversight Manager)

Trial Execution and Monitoring
• Ensure achievement of key milestones (CTN submission, FPI, LPI, etc.) in Japan
• Conduct initial Protocol Deviation (PD) assessments and track trends
• Ensure the ongoing completeness of the electronic Trial Master File (eTMF)
• Keep the Trial Management Dashboard (TMD) and portfolio app in GenSense up to date
• Drive the ODB review meeting
• Participate in RBQM activities (as implemented going forward)
• Assist in maintenance of CTT issue log in collaboration with GCTM
• Collaborate or manage study escalations both internal & external
• Support GCTM to Assess KPI/KQI at the trial level
• Support QA in site audit activities and potentially vendor audits (supporting with trial
information and collection and providing of relevant trial documents)
• Conduct booster visits
• Participate in inspection readiness activities as assigned
• Oversee and collaborate with CTT members/vendors/assigned functional representatives
on tracking and reconciliation of trial related items such as scans, blood samples etc.

Responsibilities/tasks as GCTM
Trial Leadership and Management:
• Lead the Clinical Trial Team (CTT)
• Lead the Trial Management (TM) team
• Define and manage CTT goals (together with CTT)

• Review and approve protocol and amendment changes
• Review Master ICF
• Approve operational plans, manuals and charters for the trial
• Oversee vendor selection process
• Initiate and ensure the accuracy and completeness of initial Work Order (WO) / Change Orders (CO)
• Drive country selection process
• Coordinate and respond to IEC/IRB comments
• Overview of major PDs and PD trending
• Approve data cleaning plans
• Work closely with CPL as needed for CST/CDT
• Ensure responsibility split is developed and maintained
• Review and contribute to CSR as needed
• Escalate issues to CPL in a timely manner
• Execute operational strategy related to Drug supply
• Execute regulatory submission strategy
• Execute recruitment strategy

Budget and Planning:
• Assist in initial development and Manage trial budget
• Plan, implement & ensure maintenance detailed integrated trial timelines from study
outline though CSR (Gap: GCTM/CPL need a planner, e.g., MS Project, to show end to
end project timelines and to build trust in organization)
• Develop initial recruitment projections and strategy
• Approve re-baseline recruitment projections in alignment with CPL
• Act as counterpart for CRO PL/PM and approve CV of PL/PM
Risk management:
• Conduct study risks identification with CTT & risks management activities
• Oversee CTT issue log and issue resolution
• Oversee CTT Action/Decision logs are maintained
• Assist in preparation for & responses to audits
• Ensure CAPAs are in place, if applicable

Japan specific responsibilities/tasks
Drug Development in Japan:
• Represent JDO in one or more J-CoT
o Work with JCTM to ensure each study progress and milestone achievement in
Japan
o Ensure that departmental input/knowledge that could impact the setup and
conduct of trials is proactively considered and discussed upon operationalization of the trials
o Proactively provide input on the development strategy of compound as a
representative of JDO

• Participate in preparation for and response to PMDA Inspection as a representative of JDO
• Proactively join a cross functional activity including a process development/improvement
• Collaborate with critical external stakeholders (e.g. CROs, vendors, experts) to drive long-term objectives across projects/programs, if applicable
• Participate in external initiatives/task force teams such as EFPIA and JPMA and bring experience and knowledge to the relevant stakeholders, if applicable
• Mentor other colleagues
The Employee shall also render such other related services and duties as may be assigned from time to time by supervisor.

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