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■休日：完全週休二日制, 土, 日, 祝日, 年末年始

Job Description

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with venders; and other duties, as assigned
- Assures the implementation of project plans for the clients as assigned at the client office, where you will be dispatched
- Responsible for all aspects of site management as prescribed in the project plans
General on-Site Monitoring Responsibilities:
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs ) or other data collection tools by careful source document review. Monitor data for missing or implausible data
- Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy
- Prepare accurate and timely trip reports
- Manage small projects under direction of a Project Manager/Director as assigned
- Serve as lend monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned
- Review progress of projects and initiate appropriate actions to achieve target objectives
- Organize and make presentations at Investigator Meetings
- Participate in the development of protocols and Case Report Forms as assigned
- Participate in writing clinical trial reports as assigned
- Interact with internal work groups to evaluate needs, resources and timelines
- Act as contact for clinical trial supplies and other supplies (vendors) as assigned
- Responsible for all aspects of registry management as prescribed in the project plans
- Undertake feasibility work when requested
- Conduct, report and follow-up on Quality Control Visit (CQC) when requested
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
- Negotiate study budget with potential investigators and assist the Fortrea legal department with statements of agreements as assigned
- Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up SAEs
- Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or clinical data management system assigned by management
- Assist with training, mentoring and development of new employees, e.g. co-monitoring
- Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contacts as assigned
- Perform other duties as assigned by management
- To be dispatched to the client for the project following the clients’ working conditions (working hours/working places)

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

This role leads the strategic planning and management of clinical development programs in Japan, ensuring regulatory compliance, risk management, and the timely execution of clinical trials. This includes coordinating with external vendors, monitoring trial progress, advancing regulatory submissions, and driving post-marketing activities.

■休日：完全週休二日制, 土, 日, 祝日

日本の規制当局対応を中心に、国内外の臨床薬理活動を科学的かつ規制面でリードします。
PK/PD評価や日本特有の規制要件に基づくフェーズI試験の設計支援、非臨床データの解釈、規制当局との交渉資料作成を担当。グローバルチームと密接に連携し、日本の規制要件を反映した開発計画を推進します。CRO管理や関連文書作成も担い、幅広い分子種の経験を活かして臨床薬理活動を統括。国内外の関係者と協働し、科学的整合性と規制対応の一体化を図ります。

■休日：完全週休二日制, 土, 日, 祝日

担当プロジェクトの臨床データに関する科学的議論や成果物の作成を担います。
グローバルメンバーや国内の治験責任医師と密に連携し、試験設計から結果報告、臨床データパッケージの作成まで幅広く対応。規制申請に必要な臨床試験の計画・実施・完了を主導し、規制当局との調整も行います。
日々の試験管理を監督し、品質やスケジュール、法令遵守を確保。医療専門知識を活かし、治験プロトコル作成や関連文書のレビュー、社内外の関係者と協働しながら臨床開発の成功に貢献します。

■休日：完全週休二日制, 土, 日, 祝日

[Job Purpose]
The Japan Vaccine Development Lead (J-VDL) is accountable for a vaccine development in Japan to ensure delivery differentiated vaccines of value for patients, stakeholders and markets in Japan. The J-VDL serves as the asset level point-of-contact for Vaccine Development Leader (=VDL), and asset single point of contact to Japan senior management and Japan governance board. JVDL must work closely with VDL not only successful launch for Japan but also overall success for GSK Global as one of the key leaders in Global Vaccine Development Team (=VDT).
[Key Responsibilities]
• Provide leadership and collaborates with the central Vaccine Development Team (VDT) to create overall integrated development strategies that support optimal medicine development for Global as well as Japan, including Integrated Evidence Plan (IEP) and Vaccine Profile. Serves as the asset level point-of-contact for the central Vaccine Development Leader (VDL).
• Acts as a single point of accountability for all aspects of a vaccine development in Japan from initiation of Japan development to launch in Japan. Provide clinical leadership and asset/disease expertise for the clinical trial program and indications in scope
• Delivers differentiated vaccines of value for patients, stakeholders and markets in Japan on time within budget, through an evidence package that supports regulatory approval, market access, and product life cycle in Japan.
• Provide Matrix Leadership in Japan (i.e. Japan Vaccine Development Team) to ensure integrated approach, robust planning, and execution oversight. Also supports differentiated development for team members; owns the performance of J-VDT and partners with line managers to drive performance. Serves as the single accountable decision maker to resolve disputes among the J-VDT.
• Works closely with the Japan Early Development Leader (J-EDL) as well as Japan Medical Lead (J-MAL) and Japan Commercial Lead (JCL) to ensure a smooth transition between the J-EDL (accountable from C2CS to initiation of Japan development) to J-VDL (accountable from initiation of Japan development to the first approval in Japan) and from J-VDL to J-MAL/JCL (accountable after the first approval in Japan).
• Asset single point of contact and spokesperson to Japan senior management and Japan governance board (e.g. Portfolio Investment Board Japan).
• Proactively identifies unmet medical needs that could be addressed through line extensions in Japan. Prioritizes and maximizes the asset’s portfolio options including developing multiple indications in Japan.
• Responsible for making recommendations to TAL/IET Leader and senior stakeholders on benefit risk assessment, Go/No-go criteria, and Clinical PoS for the program in scope
• To create the communication strategy and represent GSK externally and keep good relationship with Regulatory and government organisations
• Ministry of Health, Labor, and Welfare, PMDA
• Japanese Government (Cabinet minister, Minister office)
• National Center, Researech Institute (National Cancer Hospital etc) Scientific Societies, EEs
• Patient Groups
• CRO（PPD）
• Ensures quality & compliance oversight in line with R&D expectations and project needs; assures quality of data and science. Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement and promotional practices.
• J-VDL is accountable for delivering and managing the asset resourcing plan in Japan. In addition, the J-VDL is accountable for managing the asset budget in Japan.

■休日：完全週休二日制, 年末年始

【Local Delivery Lead (Non-Oncology)】
Provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of countries; across all therapy areas (Rx and Vx) to the required quality standards, GSK written standards, local regulations and ICH GCP.

Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (clinical, biostats, medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project management of study activities within the countr(ies).

• Serves as the operational point-of-contact between the central GSK study team and within-countr(ies) study team. The LDL collaborates closely with local clinical, biostats, medical and regulatory affairs staff to align on local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within countr(ies).
• Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local / regional regulations, IND/GCP/ICH-guidelines, GSK procedures.
• Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit / inspection quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery.
• Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.
• Identifies and resolves or escalates issues and risks that may impact study delivery.
• If needed, may provides feedback on performance, capabilities and competencies of local study members to line management. As required, will review and approve monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.
• Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
• As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.
• As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study.
• Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of disease area being studied, competitive landscape within coutnr(ies), local treatment/immunization guidelines and local health care system requirements.
• As required, assists with audits/inspections of local clinical operations department and study / sites in the countr(ies).
• Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Responsible to identify and share best practices
• Available and willing to travel as job requires.

■休日：完全週休二日制, 年末年始

The Clinical Scientist (CS) in Japan is the single point accountability for the development of the Clinical Development Plan (CDP), study design, governance and interpretation of results of the studies, and filing strategy and key messages in CTD (clinical modules) for Japan. The study design is expected to fulfil a strategic objective of the clinical development to maximize the asset values for Japan.
The CS will have accountability for approximately 2 projects (assets) at any one time and they will be required to work collaboratively alongside Japan Development, Japan Regulatory Affairs and Japan Medical Affairs colleagues, as well as with global Medicines/Vaccines Development Team (MDT/VDT) and Clinical Sciences members to drive the ongoing success of the projects
Key Responsibilities
• Single clinical development voice at the both program level & study level in Japan MDT/ VDT, Japan Early Development Team (J-EDT), and other cross-functional collaboration with Japan Medical Affairs, GAMA, Japan Commercial functions, etc.
• Lead Japan clinical development with global and local clinical leaders such as the Clinical Development Lead (CDL), Clinical Science Lead (CSL), Clinical Sciences members, Study Delivery Lead (SDL) and Local Delivery Lead (LDL). Serves as the program and study level point-of-contact in Japan.
• Lead scientific interactions with external stakeholders (e.g. regulators, EEs, investigators), and work closely and collaboratively with CDL and CSL to input Japanese requirements and co-create integrated global development plan to maximize the asset values.
• Update and deliver Clinical Development Plan (CDP).
• Develop study (e.g. Protocol, main ICF, CTN (scientific contents)) & regulatory documents (e.g. CTD, briefing documents for consultation, and answers to queries from Regulatory authority).
• Study Design: Develop study design with CSL and clinical sciences members, including integrated input from internal/external experts, and patients in Japan.
• Scientific Oversight for the Study: Respond to scientific questions arising from sites in Japan to secure the quality of study during study conduct. Ensure that study analysis plan for Japan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and results.
• Evidence Outputs: In terms of Japan analyses, interpret study data to create the scientific content of Clinical Study Report (CSR) and prepare the abstracts, posters and presentations for scientific meetings, congresses, external journal publications.

■休日：完全週休二日制, 年末年始

Job Purpose
• Provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of countries; across all therapy areas (Rx and Vx) to the required quality standards, GSK written standards, local regulations and ICH GCP.
Key Responsibilities
• Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (clinical, biostats, medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project management of study activities within the countr(ies).
• Serves as the operational point-of-contact between the central GSK study team and within-countr(ies) study team. The LDL collaborates closely with local clinical, biostats, medical and regulatory affairs staff to align on local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within countr(ies).
• Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local / regional regulations, IND/GCP/ICH-guidelines, GSK procedures.
• Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit / inspection quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery.
• Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.
• Identifies and resolves or escalates issues and risks that may impact study delivery.
• If needed, may provides feedback on performance, capabilities and competencies of local study members to line management. As required, will review and approve monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.
• Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
• As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.
• As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study.
• Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of disease area being studied, competitive landscape within coutnr(ies), local treatment/immunization guidelines and local health care system requirements.
• As required, assists with audits/inspections of local clinical operations department and study / sites in the countr(ies).
• Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Responsible to identify and share best practices
• Available and willing to travel as job requires.

■休日：完全週休二日制, 年末年始

【Job Purpose】
As an established project manager, this role drives the projects to success with fostering end to end & cross-functional way of working leveraging professional skills such as risk management, budget management, stakeholder management and resource management.

This person is expected to support the department manager and contribute organizational growth in terms of capability development of project manager, productive and patient-oriented ways of thinking.

【Key Responsibilities】
・Deliver pipelines and contribute to evidence generation in the accountable disease area by leading the project and helping Japan project leaders leveraging professional project management skill.
・Ensure pipeline delivery with the agreed project plan, schedule, and within budget and human resources.
・Responsible for identification of key risks for projects in the accountable disease area and manage them to mitigate the risks.
・Responsible for communication with global project managers to ensure projects in Japan are being aligned with global strategy
・Contribute GSK-Japan’s key decision relating to new drug development by generating project proposals and inputting key issues etc. in an appropriate and timely manner.
・Contribute to the capability development in each project managers with good interaction (discussion, information sharing, collaboration)
・To be a role model as a manager who can demonstrate GSK expectation and Culture as project manager

■休日：完全週休二日制, 年末年始

【Job Purpose】
• The Japan Clinical Operations Asset Lead (J-COAL) represents all Clinical Operations functions at the asset level in Japan and is responsible for developing the operational strategy and delivery plan to execute the scientific strategy for an asset and associated studies, working in partnership with Global COAL. J-COAL works closely with clinical / biostats and the functional subject matter experts in Japan to ensure informed asset decision-making from the operational, scientific and data perspectives. Key Responsibilities
• Contribute to the development of the Integrated Clinical Development Plan and Integrated Evidence Plan, during Research, Development and Life Cycle Management phases of the asset lifecycle. To achieve this, become a single point of contact for Global COAL.
• Resourcing strategy:
• Lead resourcing discussions in Japan, being responsible on final strategy (in vs outsourcing) for the asset, and studies, in accordance with the resourcing strategy & principles.
• Responsible for Japan input to Global COAL on assessment, selection, contracting and management of appropriate vendors for outsourced clinical activities and services, ensuring compliance with GSK standards.
• Oversight of delivery quality:
• Lead escalation point from study and asset level to raise and assist with issues on behalf of the team, including serious quality incidents and serious breaches of GCP.
• Responsible for the coordination and leadership of cross-functional team input into development plans, ensuring quality delivery of all studies included within the plans.
• For outsourced programs, oversight to ensure the quality delivery.
• Delivery plan:
• Drives innovative approaches to study execution through external facing advances in technology and sciences, by identifying and embracing risks and opportunity
Responsible for asset delivery strategy (e.g. country, diversity, patient engagement strategies etc) in collaboration with cross-functional stakeholders, with particular focus for Clinical Operations contributions to governance boards.
• Responsible for budget forecasts for clinical studies and Clinical Operations asset level costs, ensuring they are accurately represented and managed in financial tools.
• Asset level risk register, communication, and systems data
• Ensure asset level operational risk management plan is in-place and applies a smart-risk taking philosophy.
• Responsible for asset level mitigation plans are implemented to avoid and manage risk/quality issues.
• Responsible for translating the technical content of the TMP/TVP/IEP to ensure appropriate operational implementation at the study level.

■休日：完全週休二日制, 年末年始

1. Leads the Clinical Team, a cross functional, team of internal experts, through clinical phase I – III trials, and global product registration. Deal with relative complex projects (e.g. co-development with another company). Sets project-related objectives with team members. Requests clinical team members and clarifies resource availability with functional heads.
2. Act as a member of the J-Project Team representing Clinical Development (CLD) and member of the Launch team, representing CLD. Build consensus by complying input from multiple functions.
3. In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP). Responsible for planning and managing the clinical timelines, against the approved CDP. Provides domestic study concepts to ensure compliance with global strategy. Proactively initiates corrective action as needed.
4. Responsible for the ongoing risk-benefit assessment of a compound until approval in Japan. Analyses incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate.
5. In consultation with the Head of CLD and Global Clinical leader, responsible for assessments and communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities).
6. Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (J-CTD Module 2s). Consults with Global clinical leader, Clinical Science, Clinical Statistics, Regulatory, PHV. Compiles and maintains Translated Investigators’ Brochures (IB).
7. Provides medical expertise to Marketing (for marketed products and for development projects) and defines together with the Medical Affairs (MA) the publication strategy. Ensures consistency of publications with clinical data and publication strategy. Contributes to Opinion Leader development and publications strategy with implementation detail. Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development. Provides medical assessment of in- and out- licensing opportunities of development projects.
8. Conducting Clinical Development tasks independently while seeking advice on exceptional or complex topics from senior clinical leaders and/or managers

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

• 割り当てられた試験の日常的な運用と責任を管理し、適用される GCP/ICH ガイドラインおよびその他の規制要件に準拠して、確立されたプロジェクト チームの目標と目的が確実に完了するようリード
• ベンダーを含む部門横断的な試験チームを推進、サポート
• 試験実施中に発生する問題を特定し、試験関連の問題のエスカレーションを管理
• 中核となる試験文書、試験計画、システム設定の開発に参加または主導し、準備に参加してプロトコルの運用上の卓越性を確保し、適切なシステム、標準、プロセスの実装によって調査サイト、ベンダー、データ全体の品質を確保
• ベンダーの要件とプロジェクト範囲の準備および試験ベンダーの選択に参加または主導し、ベンダー試験チームとのやり取りとエスカレーションを管理
• 実現可能性の評価および試験実施国と場所の選択に参加または主導する
• 試験のマイルストーンと成果物をサポートするために、治験責任医師やスタッフとのサイトのエンゲージメントおよびコミュニケーションに参加または促進
• タイムリーなデータクリーニング、データ分析、トップライン結果の可用性の臨床的側面を監督し、データレビューおよび統計分析計画のレビューに参加
• 効果的な治験責任医師および施設モニターのトレーニングの設定および実施に参加または主導し、社内外の試験チームメンバー向けの運用および治療領域のトレーニングを調整

• 関連システムの追跡とデータを含む臨床試験の予算と関連ベンダー契約を管理
• 割り当てられた臨床試験の TMF の品質と完全性を確保
• 臨床試験チームの成果物の調整を含む検査準備活動に参加
• 必要に応じて、割り当てられた試験における患者中心の戦略の評価と実装に参加
• 割り当てられた臨床試験の責任に関する予算、スケジュール、リソースの管理を担当

■休日：完全週休二日制, 年末年始

治療領域戦略の策定に向け、医療環境の調査や主要意見者との関係構築、アドバイザリーボードの企画・準備を行います。
プログラム会議に参加し進捗を把握、専門的意見を提供してチームの意思決定を支援。グローバル臨床開発専門家との連絡役を担い、関連文書や規制対応資料のレビュー・意見提供を実施。申請書類の臨床部分も担当し、規制当局からの照会対応を準備。

■休日：年末年始

・医薬品の臨床試験パッケージの立案
・臨床試験デザインの立案
・導入候補化合物の評価

■休日：完全週休二日制

■組織のミッション
・お客さまの健康と利便性を第一に考え、健康管理から疾患の予防、診断、診療・治療、予後管理までスマートフォンを活用したシームレスな個別化サービスを提供し、医療ヘルスケア領域における社会課題の解決と、商流拡大の両立に挑戦。
・ビジネスパートナーの皆さまと協創することで、お客さまの期待を超える驚きと感動、法令遵守の上で安心・安全・高品質な製品とサービスを提供。
・日常生活しながら誰もが健康を維持・改善できる社会の実現をめざす。

■組織の業務概要
・スマートフォンログから各種健康状態を推定するヘルスケアAIの企画、設計、開発、サービス提供。
・疾患の予防、診断、治療等を目的としたメディカルAIの企画、設計、開発、サービス提供。
・上記の各種AIを実装したクラウドシステム基盤の企画、設計、開発、保守運用。

■担当いただく業務概要
<担当業務>
【下記の業務からスキルや経験に応じてご担当いただきます】
医療機器承認取得や保険収載獲得に向けた
・規制当局との折衝
・厚労省や学会、医師会、業界団体等へのロビー活動
・薬事対応
・臨床試験または治験の企画、設計、運用
・チームリーダーとして業務を牽引、後輩社員の指導・育成

<業務の魅力>
・ドコモだからこそ利用できるスマートフォンから得られるデータを分析して構築した医療機器プログラムとしてのAIを実現し、スマートフォンアプリによる疾患の予防、診断、治療などのデジタル医療の新たな文化を創造して社会に大きなインパクトを与える業務に従事できます。
・医療機器販売業を有するビジネス部門や外部パートナーとも連携しながら、スケールの大きなプロジェクトのリーディング経験を積めます。

■候補者へのメッセージ
健康寿命延伸、医療費抑制、医師不足といった社会課題解決と事業化を両立させる非常にやりがいのあるポストです。
１億会員を超えるお客さまに直接リーチできるスマートフォンを基軸としたアプローチにより、日常生活しながら、誰もが健康を維持・改善できる社会の実現を目ざし、開発体制強化の為、人材募集を行っています。
－－－－－－－－－－－－－－－－－－－－－－－－－－－－
■働き方の目安（※メンバー（業務・意向）により異なる）
　リモートスタンダード適用組織となります。
　https://group.ntt/jp/newsrelease/2022/06/24/220624a.html

■勤務地
　・自宅（国内限定）
　※業務上の必要性により、上長等から出社を命じられる場合有
■勤務地備考
　※出社の場合は以下の事業所に出社
　・事業所名：山王パークタワー
　・住所： 〒100-6190 東京都千代田区永田町二丁目11番1号
　・最寄り駅：
　　銀座線、南北線「溜池山王駅」 直結
　　丸ノ内線、千代田線「国会議事堂前駅」 直結
　・禁煙環境：全面禁煙
■転勤
　・数年単位で専門性や適性を軸に異動が発生する場合有
　※リモートスタンダード組織への異動の場合、原則転居・転勤は無
　※オフィスベース組織への異動の場合、転居が必要となる可能性有（同組織でもリモートワークによる勤務は可）
■出社に伴う費用について
　勤務事業所への出社については標準的な出社経路を事前に認定したうえで、
　その経路を用いた出社に伴い発生する費用を旅費としてお支払いします。
　※新幹線、飛行機の利用も旅費規程に基づく範囲内で利用可となる場合がございます。詳細は個人ごとに異なるため内定後ご説明いたします。
■その他
　・業務命令に基づき出社（出張）が発生する場合がございます。
　※最低出社日の指定はありませんが、業務状況に応じて出社が命ぜられる頻度が変わる可能性有
　・リモートワーク手当有：
　200 円 × 「自宅」でのリモートワーク実施日数 (3H 以上）
■残業時間について
　・所属先組織の平均残業時間は20H/月程度

■休日：完全週休二日制, 夏季休暇, 年末年始

プロジェクトマネージャーは、高品質なプロジェクト管理を通じて、日本アセット戦略チーム（JAST）が競争力のある戦略を計画・実行し、効果的な連携で医薬品を患者に届ける支援を行います。
主な業務は、チームの成果物調整、会議運営、部門横断の調整、経営層との合意形成、進捗・予算・リスク管理、関係者とのコミュニケーションです。また、業務プロセス改善やベストプラクティスの共有を推進し、後輩育成も担当します。職位は経験と評価により決定されます。

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

当該ポジションは、グローバルチームと連携し、競争力の高い開発戦略を策定・実行して、革新的な医薬品を迅速かつ効率的に患者に届けることを目的としています。
チームメンバーの目標設定や育成、リスク管理も担い、複雑な多段階資産の推進とグローバル戦略への影響力発揮を行います。

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

グローバル臨床試験の実行を担う中央チームの一員として、複数のフェーズ0～4試験の計画・実行・管理を支援します。
プロジェクトマネージャーの指導のもと、品質・効率・スケジュール・予算を遵守し、戦略目標達成に貢献。ベンダー管理、被験者募集戦略の立案・実行、会議運営、リスク管理、関連文書の作成・管理、システム運用支援など多岐にわたる業務を担当。検査対応や教育支援、プロセス改善にも積極的に関与します。

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

JOB SUMMARY
The Senior Clinical Trial Manager ( CTM) serves as the clinical functional lead, accountable for the clinical
monitoring/site management delivery of assigned tasks and project(s) as per scope. The Senior CTM may
provide oversight and coordination of CTM(s) working across regions and/or countries to ensure clinical
project and site deliverables are met. The position provides leadership, mentoring, and technical support
to the Clinical Operations team to ensure quality deliverables and achievement of milestones and
financial goals. May provide administrative line management, which includes oversight of training,
compliance, performance, development and career management of direct reports.
JOB RESPONSIBILITIES
As defined by scope may be responsible for team member clinical/site management project deliverables
as the clinical functional team leader. Drives and manages the clinical and site management aspects of
assigned project. May be a standalone lead or part of a regional or global clinical functional lead team.
Reviews the study scope of work, budget and protocol content and ensures the clinical project team
(CRAs/CMAs/SMAs) is aware of the parameters. Escalates to the PM any clinical/site management
deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of
contracted scope. Ensure alignment of clinical activities to budget, including identification of out of scope
activities.
 Globally reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug
management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Strategic Data Monitoring
(SDM) and/or other dashboards to oversee site and project team conduct, ensures timely entry of
all operational aspects (required visits, duration, and frequency) according to plan, and identifies
risks to delivery or quality.
 Coaches and mentors CTMs regarding functional clinical delivery, evaluation of project risks, and
action implementation. Also sets priorities for the CTM team to complete and manage on a regional
and site level.
 Ensure quality of the clinical monitoring and site management deliverables within a project and/or
program and maintain proper visibility of its progress by the use approved systems and / or tracking
tools. May include the development of the Clinical Management Plan (CMP)/Site Management
Plan (SMP).
Understands the monitoring strategy required for the project and, where required, participates in the
development of the project risk assessment plan. Is accountable for the clinical teams’
understanding, ongoing compliance and delivery, according to the stated monitoring strategy,
CMP/SMP, and risk plans
 Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit
reports, site letters, and pertinent correspondence), to ensure they represent site management
activities and conduct. Ensures these deliverables are provided according to company and/or
sponsor specifications, including delivery deadlines
 Maintains compliance on the project(s) for performance deliverables, and associated KPIs.
 Interact with the client and other functional departments related to clinical monitoring and site
management activities and deliverables.
 Collaborates with other functional areas to ensure site compliance and delivery according to
protocol, ICH/GCP and/or Good Pharmacoepidemiology Practices (GPP) and country regulations,
including medical monitoring, Safety, Quality Assurance (QA). Ensures Inspection Readiness for
Clinical Scope.
 Ensures alignment of clinical activities to budget, including identification of out of scope activities.
 As required, provides development and delivery of initial and ongoing training to the study team
regarding protocol specifics, Case Report Form (CRF) completion, Sponsor Standard Operating
Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the project. Plans
and leads regular clinical project team calls to provide status updates, ongoing training and
accountability to deliverables.
 As defined by scope may oversee the global project process and status of monitoring and data flow.
Reviews status and trends at the study level, holds CTM team accountable to manage at site and
regional level for effective and timely Source Document Review (SDR) and/or Source Document
Verification (SDV) and data flow, reviewing status of site and project eCRF entry, SDV, triggered
monitoring conduct, query response, and data cleanliness. Proactively collaborates with data
management functional lead to plan towards data cut and lock deadlines. Develops and executes
corrective action plans at study (global) level to address any issues.
 May evaluate staff’s competency to perform visits/site contact independently via sign-off visits and
Monitoring Evaluation Visits (MEVs) according to company standards and process.
 May participate in business development activities including project clinical operations/site
management strategy and budget input, defense meetings and proposal development.
 May be involved in Business Unit or corporate initiatives, serving as a Clinical Operations SME.

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始