求人・転職情報

■ 職務内容 / Job Description
Clinical Scientist (CS) is a clinical project lead with strong experience in multidisciplinary aspects of drug development and is accountable/responsible for generating clinical development strategy, designing clinical development options, and delivering successful clinical development programs for responsible AZ assets in Japan. 
His/Her accountability/responsibility is balanced between project-level and study-level activities, depending on his/her experience and expertise, in order to achieve deliveries of both projects and studies. 
Other major responsibilities/accountabilities include but are not limited to:
・Co-developing the documents for regulatory interactions such as BD for regulatory consultation, query responses, Sakigake application, ODD application, etc, 
・Authoring clinical/medical part of CTD and responses to queries 
・Acting as a key point of contact for clinical development related relationship with external experts. 
・Leading development of clinical science part of clinical trial documents, and providing support for the Study Level Safety Review activity, for Japanese standalone development projects,
・Inputting to publication strategy and contents/quality of publications. 
・Guiding and supporting other Clinical Scientists at career level D. (Career Level Eの場合)

The Associate Director – Cell Therapy Territory Operations Manager (AD-TOM) is a regional expert supporting Patient Operations and project teams in cell therapy. As a senior technical leader, the role sets and implements compliant policies and standards for treatment centers, partners with Regional Operations Directors (RODs) on site strategy, leads research and internal reporting, and maintains up-to-date best practices.
The role expands AZ’s cell therapy footprint in oncology by building patient-centered service lines and leading complex engagements with site leadership and frontline providers. It delivers operational and clinical guidance for trials and commercial products, leads site activation, and provides ongoing operational, quality, and clinical oversight post-activation. The AD-TOM is a field, regional role reporting to a Regional Operations Director (ROD).

You Will:
 • Lead and support strategic initiatives across clinical and commercial cell therapy from development to post-market.
• Be a key leader within Internal AZ teams (Program Management, QA, Manufacturing, Supply Chain, Medical Affairs, Market Access, Compliance, Sales/Marketing).
• Establish service lines with external partners (PIs, Physicians, Nursing, Apheresis, Cell Therapy Lab, other HCPs/leadership).
• Serve as SME, driving decisions and projects at multi-country/local levels; influence strategy, governance, and cross-functional execution.
• Acts as the technical expert and authoritative source of knowledge in cell therapy workflows and brings expertise to site interactions.
• Build and maintain relationships with stakeholders at assigned Sites.
• Operate within regulatory/accreditation standards (e.g., FACT) ensuring compliance, audit readiness, and continuous improvement.
• Guide clinical workflows; ensure standards; advance apheresis excellence; optimize product handling; inform health outcomes.
• Act as primary operations readiness liaison; collaborate with Supply Chain to align logistics and site needs.
• Provide exemplary customer service while building business relations with clinical/operational leaders.
• Lead cross-functional meetings to develop product/patient workflows for trials and future commercial products.
• Maintain strong collaboration with Program Management, SMM, Supply Chain, Manufacturing, Quality, Medical, Commercial, Cell Therapy Hub, to manage customer centers and clinical care for the portfolio.
• Oversee operational/clinical aspects of raw material collection, product receipt/storage/distribution/infusion, and COI/COC.
• Design and deliver training to PIs, MD, Nursing Staff, Apheresis, and Cell Therapy Laboratory and Coordinator staff
• Lead Site activation using risk-based tools for certification, training, and monitoring.
• Train Site HCPs on product needs; ensure COI/COC access for trained individuals with Cell Therapy Hub.
• Oversee Site logistics and manage regional account changes with Cell Therapy Hub.
• Respond to SOP deviations with expertise and collegiality.
• Support/own quality records (Deviations, CAPA, Change Control) with Cell Therapy Hub and QA.
• Travel up to 50%. 

このジョブ・ポジションは、担当する開発プロジェクトにとって最適なゴールとそのゴールに到達するための道筋（開発戦略）を描き、常に開発プロジェクトにとって最良の視点に立ってプロジェクトチームメンバーと対話し、開発プロジェクトチームのOne Voice形成をリードする役割を担います。

【主な役割・責任・権限】
- 開発プロジェクトの製品戦略に基づく開発戦略を策定し、管理・更新する
- プロジェクト関係者及び社内外のステークホルダーとの関係構築と折衝を行う（プロジェクト関係者と連携をし、社内ステークホルダーを含むファンクション間の調整を行う。担当プロジェクトに関わるKOLを含む社外ステークホルダーとの関係を構築及び維持し、上位者と共に折衝を行う）
- プロジェクト計画に関して開発部門内の意思決定会議に提案し承認を得る（担当プロジェクトの提案内容に対する説明責任を負う）
- その他、合理的に必要とされる所属組織や機能に関連する業務、および組織能力向上（人材育成・組織開発）を行う

本ポジションの魅力
多岐の業務にわたる開発プロジェクトチーム（骨・ミネラル、希少疾患、再生医療等製品、等）を統括し、グローバル開発（または国内開発）の中心的な立場で業務に携わることができます。
多様なステークホルダーと協働し、医科学・薬事・ビジネスを統合した最適な開発戦略を策定し、意思決定会議に提案する立場を経験できます。
開発戦略の立案及び開発プロジェクトの推進を通じて、患者さん中心の医療価値創造に携わり、社会が真に求める治療選択肢を創出し、実行へと移すことで社会への貢献を実感できます。

このジョブ・ポジションは、担当する開発プロジェクトにとって最適なゴールとそのゴールに到達するための道筋（開発戦略）を描き、常に開発プロジェクトにとって最良の視点に立ってプロジェクトチームメンバーと対話し、開発プロジェクトチームのOne Voice形成をリードする役割を担います。

【主な役割・責任・権限】
- 開発プロジェクトの製品戦略に基づく開発戦略を策定し、管理・更新する
- プロジェクト関係者及び社内外のステークホルダーとの関係構築と折衝を行う（プロジェクト関係者と連携をし、社内ステークホルダーを含むファンクション間の調整を行う。担当プロジェクトに関わるKOLを含む社外ステークホルダーとの関係を構築及び維持し、上位者と共に折衝を行う）
- プロジェクト計画に関して開発部門内の意思決定会議に提案し承認を得る（担当プロジェクトの提案内容に対する説明責任を負う）
- その他、合理的に必要とされる所属組織や機能に関連する業務、および組織能力向上（人材育成・組織開発）を行う


本ポジションの魅力
・多岐の業務にわたる開発プロジェクトチーム（血液がん・難治性血液疾患）を統括し、グローバル開発（または国内開発）の中心的な立場で
　業務に携わることができます。
・多様なステークホルダーと協働し、医科学・薬事・ビジネスを統合した最適な開発戦略を策定し、意思決定会議に提案する立場を経験できます。
・開発戦略の立案及び開発プロジェクトの推進を通じて、患者さん中心の医療価値創造に携わり、社会が真に求める治療選択肢を創出し、
　実行へと移すことで社会への貢献を実感できます。

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.

製薬メーカー・バイオテックの新薬開発プロジェクトが拡大中の現在、
Project Managerの増員が急務となっており、未経験Project Managerの採用を実施することになりました。
臨床試験におけるProject Management業務（主にグローバル試験）をお任せいたします。
【詳細】
・クライアントの状況、組織・チーム体制、関係性などの期待を把握し、適切な期待値調整やステークホルダーマネジメントを実施する
・プロジェクトにおける情報や成果物の進捗管理、リスクマネジメント、クライアントへのレポートを行う
・クライアントの最終的なゴールと、臨床開発計画およびプロジェクトとの整合性を取りながら、適切な提案やすり合わせを行っていく
・モニタリング以外の部門（海外のチームを含む場合あり）や、外部パートナー（ベンダー）も含めて、各ファンクショナルチームをサポートし、リードする
・プロジェクトの進捗状況と指標を継続的にレビューし、適切なフォローアップアクションを実行して、クライアントとの契約上の合意事項や合意項目（納期、品質/範囲、およびコスト）を確実に順守する
・プロジェクトのリスク・問題について、プロアクティブに特定、解決、およびエスカレーションを実施する（プロジェクトチームのエスカレーションポイントとして対応する）
・経験の浅いメンバーへの適切な指導による成長への貢献

【入社後のトレーニングについて】
一定期間の（約3 ヶ月間）の社内トレーニングと同時並行で、Project Managerとしてpartial（部分的）アサインされ、先輩Project ManagerからのOJT 下で、PMの業務を実務レベルで対応いただく予定となっております。

臨床試験におけるProject Management業務（主にグローバル試験）をお任せいたします。

・クライアントの状況、組織・チーム体制、関係性などの期待値の把握、適切な期待値調整やステークホルダーマネジメントの実施
・ プロジェクトにおける情報や成果物の進捗管理、リスクマネジメント、クライアントへのレポート
・クライアントの最終的なゴールと、臨床開発計画およびプロジェクトとの整合性を取りながら、適切な提案やすり合わせの実施
・モニタリング以外の部門（海外のチームを含む場合あり）や、外部パートナー（ベンダー）も含めた、クロスファンクショナルチームのサポート、およびリード
・プロジェクトの進捗状況と指標の継続的なレビュー、適切なフォローアップアクションの実行、クライアントとの契約上の合意事項や合意項目（納期、品質/範囲、およびコスト）の確実な順守
・プロジェクトのリスク・問題について、プロアクティブに特定、解決、およびエスカレーションの実施（プロジェクトチームのエスカレーションポイントとして対応）
・経験の浅いメンバーへの適切な指導による成長への貢献

■Position Summary
You will lead epidemiology initiatives in Japan to inform development and lifecycle decisions. You will partner across clinical, safety, regulatory and commercial teams. You will shape study design, manage external partnerships, and translate real-world evidence into clear recommendations. We value curiosity, collaboration, and a practical approach that balances scientific rigour with timely decision-making. Join us to grow your career while helping GSK unite science, technology and talent to get ahead of disease together.

■Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:- Lead design, delivery and interpretation of epidemiology studies and real-world evidence projects in Japan.- Provide clear epidemiologic input to cross-functional teams including clinical development, safety, regulatory and market access.- Manage external partnerships and vendors to access data, deliver studies and ensure quality and timelines.- Produce study documents and outputs: protocols, analysis plans, final reports, regulatory input and scientific communications.- Represent GSK in scientific and regulatory discussions in Japan and with external experts.- Mentor colleagues and contribute to knowledge sharing and process improvements across the Epidemiology team.

[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.

■プロジェクトの開始、メンテナンス、および終了までの全てのプロジェクトに関わる活動が計画通りに動くよう、関連各部署との調整及び管理
■Medpace Japanにおける担当試験の代表として、スポンサーと良好な関係を構築し（グローバルが窓口となる場合は、グローバルと密に連携し、グローバルを支援する）、適宜、情報共有、課題解決に向け協議
■Medpace Japanにおける担当試験の代表として、グローバルチームの関係者と良好な関係を構築し、適宜、情報共有、課題解決に向け協議
※グレードII以上のCTMには、ラインマネージャーとして部下の管理、指導、教育

Important duties and responsibilities associated with the job.
・Effective Management of a project including:
・ Coordinate and manage project start-up, project maintenance, and project close-out activities;
・Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact for Sponsor and all project team members;
・Track study status including patient status, Case Report Form status, safety issues, timelines, etc.;
・Serve as primary contact for protocol interpretations and logistical project-related issues (internal and external);
・Provide management oversight for Clinical Research Associates and Project Coordinators on project team;
・Interpret contract-related issues and coordinate Medpace activities according to current scope;
・Develop study management tools, including communication plan, clinical monitoring plan, patient recruitment and retention plan;
・Communicate change in scope to Sponsor clinical team and Medpace Contract Manager.

Provide input for following (when applicable):
・Study protocol
・Edit Check Specifications
・Data Analysis Plan
・Data clean-up results
・Analysis
・Final study report

Contacts
Principle recurring contacts, including their frequency and purpose.
・Frequent contact with Sponsor, other contractors, and sites (external); and
・ Ongoing review of process and timelines for study progress with project team members and supervisor (internal).

Physical Demands and Working Conditions
Description of disagreeable conditions, physical activities, potential hazards, and travel associated with the job.
・The employee will be expected to travel for project-specific meetings.

■Position Summary:
Director Clinical Operations/Director Clinical Operations TA Head is accountable for the operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The Director Clinical Operations/Director Clinical Operations TA Head supports Country Head in shaping and managing local organizational structure to ensure its optimal efficiency. This individual is responsible for line management of Functional Managers (FM)/Clinical Research Managers (CRM), and/or other GCO staff, as required. Oversees staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/Global Development (GD) overall.


■Principal Responsibilities:
1. Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
2. Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
3. Responsible for deployment of the One Delivery Model through collaboration and oversight of vendors.
4. Accountable for the acquisition of new talents and development of human resources.
5. Guide direct reports in issue resolution and communication with involved stakeholders.
6. Lead organizational changes and effectively communicate on priority shifts as required.
7. Review and approve expenses in compliance with the company policies.
8. Demonstrate leadership behaviours in alignment with J&J Leadership Imperatives
9. Foster an environment that encourages sharing of ideas, information, and best practices (internal and external to the organization).
10. Provide coaching and mentorship as needed.
11. Define, execute or support of long term strategy in alignment with GCO, GD and JJIM R&D strategies to position the local and global GCO organization for success.
12. Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
13. Accountable for ensuring relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
14. Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct, and health care compliance breach. Contribute to CAPA and issue resolution in accordance with required timelines.
15. Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs).
16. Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other area of responsibility, as required.
17. Oversight of feasibility process and site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
18. Review operational and quality metrics regularly and drive follow-up actions as appropriate.
19. Drives innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/GD overall. Foster a culture of continuous improvement and innovation within the local GCO team.
20. Model Credo based culture within the local GCO team.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.


■Principal Relationships:
・Primary Reporting Structure: Reports to Country Head or equivalent
・Primary interfaces: Country Head, other Director Clinical Operations/Director Operations TA Head, Program Delivery Leaders (PDL)/Trial Delivery Leaders (TDL), Strategic Account Leads (SAL) and supporting roles in the country.
・Other Internal Interfaces: Local Trial Managers (LTM), Site Managers (SM), Clinical Trial Assistants (CTA), R&D/Local Operating Company staff (including Medical Affairs), departments within and outside of GCO/GD, i.e. Delivery Units (DU), Integration and Process Optimization, Integrated Data Analytics & Reporting (IDAR), BRQC, HCC, External Alliances, Contracts & Centralized Services (CCS) and others as required.
・External Interfaces: Functional management of relevant vendors, Health Authorities, Ethics Committees, investigational sites, local vendors and others as required.

<概要>
・海外製薬会社・バイオベンチャー・研究機関から依頼されたプロジェクト（企業治験、医師主導治験、製造販売後臨床試験、臨床研究）の進捗、品質、予算、ステークホルダー等を管理する業務全般、またはそのサポート
・日本企業・研究機関から依頼された海外で実施するプロジェクト（企業治験、医師主導治験、製造販売後臨床試験、臨床研究）の進捗、品質、予算、ステークホルダー等を管理する業務全般を担当、現地PMを含む海外関係会社のコーディネート、またはそのサポート

◆仕事の魅力
・海外顧客のありとあらゆる臨床開発案件の対応をするため、最新の医薬品開発や画期的な研究に携わることができます
・自らの交渉力と社内・社外への調整力、臨床開発の経験を駆使して難局を乗り切ってミッションを完了する楽しさがあります
・実務経験の蓄積、自己啓発によるスキル向上にて、Senior Project Manager, Consultant (Subject Matter Expert)やLine Managerへのキャリアが開けます
・海外顧客や海外ベンダーとの対応があるため、在宅勤務を活用した柔軟な勤務が可能です

<概要>
・海外製薬会社・バイオベンチャー・研究機関から依頼されたプロジェクト（企業治験、医師主導治験、製造販売後臨床試験、臨床研究）の進捗、品質、予算、ステークホルダー等を管理する業務全般、またはそのサポート
・日本企業・研究機関から依頼された海外で実施するプロジェクト（企業治験、医師主導治験、製造販売後臨床試験、臨床研究）の進捗、品質、予算、ステークホルダー等を管理する業務全般を担当、現地PMを含む海外関係会社のコーディネート、またはそのサポート

◆仕事の魅力
・海外顧客のありとあらゆる臨床開発案件の対応をするため、最新の医薬品開発や画期的な研究に携わることができます
・自らの交渉力と社内・社外への調整力、臨床開発の経験を駆使して難局を乗り切ってミッションを完了する楽しさがあります
・実務経験の蓄積、自己啓発によるスキル向上にて、Senior Project Manager, Consultant (Subject Matter Expert)やLine Managerへのキャリアが開けます
・海外顧客や海外ベンダーとの対応があるため、在宅勤務を活用した柔軟な勤務が可能です

<概要>
・海外製薬会社・バイオベンチャー・研究機関から依頼されたプロジェクト（企業治験、医師主導治験、製造販売後臨床試験、臨床研究）の進捗、品質、予算、ステークホルダー等を管理する業務全般、またはそのサポート
・日本企業・研究機関から依頼された海外で実施するプロジェクト（企業治験、医師主導治験、製造販売後臨床試験、臨床研究）の進捗、品質、予算、ステークホルダー等を管理する業務全般を担当、現地PMを含む海外関係会社のコーディネート、またはそのサポート

◆仕事の魅力
・海外顧客のありとあらゆる臨床開発案件の対応をするため、最新の医薬品開発や画期的な研究に携わることができます
・自らの交渉力と社内・社外への調整力、臨床開発の経験を駆使して難局を乗り切ってミッションを完了する楽しさがあります
・実務経験の蓄積、自己啓発によるスキル向上にて、Senior Project Manager, Consultant (Subject Matter Expert)やLine Managerへのキャリアが開けます
・海外顧客や海外ベンダーとの対応があるため、在宅勤務を活用した柔軟な勤務が可能です

<概要>
・海外製薬会社・バイオベンチャー・研究機関から依頼されたプロジェクト（企業治験、医師主導治験、製造販売後臨床試験、臨床研究）の進捗、品質、予算、ステークホルダー等を管理する業務全般、またはそのサポート
・日本企業・研究機関から依頼された海外で実施するプロジェクト（企業治験、医師主導治験、製造販売後臨床試験、臨床研究）の進捗、品質、予算、ステークホルダー等を管理する業務全般を担当、現地PMを含む海外関係会社のコーディネート、またはそのサポート

◆仕事の魅力
・海外顧客のありとあらゆる臨床開発案件の対応をするため、最新の医薬品開発や画期的な研究に携わることができます
・自らの交渉力と社内・社外への調整力、臨床開発の経験を駆使して難局を乗り切ってミッションを完了する楽しさがあります
・実務経験の蓄積、自己啓発によるスキル向上にて、Senior Project Manager, Consultant (Subject Matter Expert)やLine Managerへのキャリアが開けます
・海外顧客や海外ベンダーとの対応があるため、在宅勤務を活用した柔軟な勤務が可能です