Senior Manager / Manager, Japan Clinical Trial Manager

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 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) Document Name: Job Description Document

• 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

• Ensure that departmental input/knowledge that could impact the setup and conduct of trials is proactively considered and discussed upon operationalization of the trials

• 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.

Competencies

• Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence

• Experience in leading & managing global teams

• Experience in clinical drug development & ICH-GCP/J-GCP

• Experience in trial management including budget and milestone management

• Experience in mentoring CTMs and CTAs

• Planning and budget management skills

• Outsourcing and vendor management experience

• Ability to anticipate risks and issues with proactivity to offer solutions & to timely escalate issues when needed

• Ability to foster a "One Team" spirit, inclusive mindset

• Confidence to challenging status-quo thinking and behavior; can work with agility and an innovative mindset

• Ability to think/behave or make decisions from the perspective of Management and/or Line Manager

• Ability to align with Corporate, Dev Ops, Trial Management, and CDT goals

• Excellent written and oral communication skills in both Japanese and English

• Oncology experience strongly recommended

場所

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