Senior Manager, Clinical Trial Manager

extranotordinary

Overview

The Sr. Manager Japan Clinical Trial Manager (JCTM) is accountable for delivery of Japan and/or selected deliverables within a trial (e.g. manage and oversee vendor deliverables collaborate with functions to set up activities e.g. eCRF IRT eRT support site activation and recruitment support data review/cleaning activities support PI/ICF development). Scope of responsibilities depending on number of patients/sites/size of trial.
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 Investigators 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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