Senior Manager, Japan Clinical Trial Manager

ジェンマブは革新的な抗体医薬の開発に注力し患者さんの生活を改善することに力を尽くしています

私たちはextranotordinary な未来を共に築くことを使命とし革新的な抗体製品の開発や人々を感動させる抗体医薬品でがんやその他の深刻な病に苦しむ患者さんの生活を根本的に変え治療の未来を切り拓いています

ジェンマブは思いやりがあり率直で患者さんに貢献したいという強い思いを持った人たちがともに働き科学に基づく変化をもたらします大胆さと高潔性を持って行動し新しい未来をつくることを目指すこと がこの使命を果たすために不可欠だと信じています

私たちは大きな志を掲げ楽しくそして思いやりの心を忘れずに日々意義のある仕事に取り組んでいます私たちは個々のユニークな貢献を受け入れそれらを原動力として患者ケアパートナーご家族そして社員のニーズを満たす革新的なソリューションを生み出し育み維持するグローバルな企業文化の構築に努めています

私たちの想いに共鳴し自分らしく活躍できそうだと感じたらぜひ一緒に働きましょう

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.

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

ジェンマブは可能な限り柔軟な働き方を取り入れることで社員のワークライフバランスの向上に取り組んでいます

私たちのオフィスはオープンな環境の中で従業員同士がつながることを目的としていますオフィスでもリモートワークでもお互いにつながることを大切にしイノベーションを生み出します

ジェンマブについて

ジェンマブは革新的抗体医薬を通じて患者さんの生活を向上させることを目指すグローバルバイオテクノロジー企業です

25年間情熱的で革新的そして協力的なチームが次世代抗体技術プラットフォームを開発しトランスレーショナルサイエンス定量科学データサイエンスを活用することで独自のパイプラインを確立してきましたこのパイプラインには二重特異性T細胞エンゲージャーbispecific T-cell engagers抗体薬物複合体ADC次世代免疫チェックポイントモジュレーターエフェクター機能強化抗体などが含まれています

ジェンマブのビジョンは2030年までに人々を感動させる抗体医薬品でがんやその他の深刻な病に苦しむ患者さんの生活を根本的に変えることです

ジェンマブは1999年に設立されたデンマークコペンハーゲンに本社を構え北米ヨーロッパアジア太平洋地域に国際的な拠点を展開しています

ジェンマブでは候補者個人データ及びプライバシーを重要なものと認識しており個人情報の保護に関する法律その他の関係法令を遵守しています個人情報の取扱いにご同意いただいた上ご応募ください

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