・ヒト検体を用いた網羅的遺伝子解析（WES、RNAseq等）
・オミクスデータと臨床データとの統合解析
・創薬標的及び疾患バイオマーカーの設定及び探索

■休日：週休二日制, 祝日, 年末年始, 土, 夏季休暇, 日

■職務概要
SSU（Site Start Up）Specialistとして、施設選定後から契約までのスタートアップ業務を担当頂きます。通常のCROではモニターが担当しているこの業務を、当社ではSSUが主担当としてCRAとパートナーを組み実施します。おもに電話又はメールを通して社外とやり取りをする内勤ポジションとなります。

■職務詳細
・ チームメンバー、社内各担当、 スポンサー等と協力して、治験文書提出・契約書締結・費用の合意に向けた準備・交渉・調整を実施
・ 個々の施設における治験文書および契約書の準備状況について、チームメンバーに情報提供・共有
・ 手順書に従い、チェックシートを用いて必須文書のQC点検を実施
・ 施設の問題を解決し、状況をリーダーに報告
・ 業務に関連したデータをデータベースに入力・管理
・ 部門内の経験の少ないスタッフへの指導やメンタリングを実施

■休日：完全週休二日制, 土, 日

■製薬会社から受託しているプロジェクトの治験実施計画書に基づき、治験チームリーダーが作成するモニタリング管理計画書（ＣＭＰ）に従ってモニタリング業務を実施

[職務詳細]
・担当プロジェクトにおいて定められた期間内に必要な症例数並びに品質基準を満たす症例報告書を入手し、ＳＤＶを行い、モニタリング報告書を作成
・被験者における有害事象の確認と重篤有害事象への対応
・将来的には、グループ内の若手モニターの指導、育成も担当

■休日：完全週休二日制, 祝日, 年末年始, 土, 日

■ 職務概要
臨床開発プロジェクトの進捗・品質・予算等を総合的に管理するプロジェクトマネジメント業務

・臨床開発プロジェクトのタイムラインの管理
・プロジェクトに関する提案、契約締結
・社内の調整・進捗管理（主に、プロジェクトメンバーとなるCTL、CRAなど）
・プロジェクトの予算管理・調整
・リスクマネジメントプランの作成
・開発戦略提案、ビッドへの参画、契約締結に向けた交渉
・開発他部門との調整、進捗管理
・グローバル治験・アジア治験においては、日本発信のプロジェクトをマネジメント
・他国CPMとの協業

■休日：完全週休二日制, 祝日, 年末年始, 土, 日

■業務内容
Late Phase試験におけるProject Management補佐業務を実施いただきます。
システム上での作業や、レポート作成、Trackerの活用、アクションアイテムの策定等、日々のプロジェクト管理業務と、社内外の会議への出席と議事録作成をご担当いただきます。

・特徴
Late Phase部門でのPSポジションとして、日本では初の採用となります。
グローバルへのレポーティングとなり、メンターがついて丁寧にオンボードのサポートを行います。
本のStudyをご担当いただくため、時差の対応は発生しません。
Late Phase部門では残業ゼロを目標としており、現PSの残業時間はとても少なくなっておりますため、良好なWLBが保つことが可能です。
将来的にPMを目指したい方、英語力を活かして自由に働きたい方にお勧めのポジションです。

■休日：完全週休二日制, 年末年始

社内の研修/教育業務全般
未経験CRA、COS（CTA）の方へのトレーニングに携わって頂きます


1. Act as Manager and Coach for the CRA I during the training program
2. Work with Program Director and/or other trainers to properly provide training to CRA Is during the 3-4 month program
3. Makes follow up about the performance and metrics of the trained CRAs after the project work utilization until the CRA I is promoted to CRA II role
4. Provide daily support to the trainees and timely feedback about the performance and training progression
5. Conduct 1:1 meetings and group meetings with CRA Is
6. Evaluate performance on Toll Gates and Sign-off Visits and generally assess Trainee progress and suitability for CRA role
7. Oversight on Training Visits at an assigned project, arrange and evaluate on Sign-off Visits with qualified assessor
8. Assist in recruiting new staff as required
9. Ensure CRA I Training Program timelines and requirements are met
10. Provide expert operational oversight and guidance to support prioritisation of activities, review and monitor the work performed, and development of contingency plans during the CRA I training program
11. Ensures quality and adherence to SOP/WI. Ensures all staff follows required training and completes the required documentation.
12. Updates the training program for the junior CRAs and optimizes the training program according to the Japan regulations
13. Ensures staff retention and turnover rates within the expected ranges

■休日：完全週休二日制, 年末年始

＜業務内容＞
-グローバル試験の立ち上げ進捗管理（Kick of Meeting~RGL取得までのプロセスを、専用社内システムを用いて管理）、現場からの質問対応、書類・費用のレビューなども実施
-業務上のカウンターパート：スポンサー、PM、Lead CRA、SSU Specialist、SSU Manager、GlobalPDLなど
-レポート先:AssociateDirector（オーストラリア拠点）

【JOB RESPONSIBILTIES】
・ Collaborates with major functional area leads (SSU Country Managers, Project Management,
Clinical Management,) to identify and evaluate fundamental issues pertaining to Site Start-Up,
project regulatory pathway, successful patient enrollment, interpret data on complex issues, make
good business decisions, and ensure solutions are implemented. Ensures all project deliverables
meet the internal and customers’ expectations as per contracted deliverables, providing accurate
projections, reports and updates, and ongoing risk assessments.
・ Develops and maintains relationships with customers in alignment with their assigned projects.
May collaborate with business leads for business development, alliance management, contracts and proposals development, project management, and clinical management to achieve project goals. Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed. Contributes to change initiatives across and within the SSU department.
・ Provides oversight of all project SSU deliverables which encompasses all activities from site selection through site activation ready.
・ Assumes accountability on SSU deliverables including, but not limited to:
- Start-up regulatory activities (submissions, oversight of communication to competent
authorities/ethics committees, import/export licenses, study maintenance submissions)
- Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites
- Establishing Essential document collection leading to site activation;
- Overall SSU timelines to site activation.
・ Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies all controlled document requirements and other requirements to ensure quality deliverables.
・ Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.
・ Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team.
・ Reviews the project SSU budget with the functional leads, PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations.
・ Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures minimum hours are used for tasks. If out-of-scope work is requested,notifies the PM and SSU Manager and tracks out-of-scope work until it is assigned to back log.
・ Prepares the core submission documents and core clinical trial application dossier.
・ Assists in development of master Patient Information Sheet (PIS) /Informed Consent Form (ICF) in collaboration with the PM and medical department.
・ Oversees collation, quality review, and submission of country-specific applications.
・ Accountable for the timely follow-up for Ethics Committee/Competent Authority enquiries or objections in collaboration with the country SSU Specialists. Meets or exceeds the planned submission/approval timelines; if forecasted timelines are not reached or if any potential issue is
identified, solves or escalates the problem quickly.
・ Accountable for the oversight of negotiation and execution of clinical trial agreements and budgets in accordance with agreed timelines. Includes coordination of internal and external stakeholders in the development and/or provision of required clinical trial agreement templates and investigator site budgets, oversight of local contract negotiator colleagues and assistance in resolving negotiation barriers, and periodic progress reporting to the client and other stakeholder groups.
・ Identifies best practices and participates in process improvement initiatives in conjunction with the global SSU leadership plan and project deliverables.
・ Participates in new business development activities including participation at client presentations.Provides information to support business development activities.

■休日：完全週休二日制, GW, 祝日, 年末年始, 土, 日

・業務内容
SSU Specialistが立ち上げた施設の立ち上げ後の対応をメインで実施いただきます（契約変更等の対応）。
業務稼働によっては、立ち上げ業務をサポートいただく可能性もあります。

※ワークライフバランス良い環境です。
離職率も全体で5％台と長期でご就業していただけます。

【Job responsibilities】
• Provide support with site selection lead and Project Manager (PM)/SSU Leadership (SSUL) to ensure
that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
• Assists in administration of contract management and essential document processes, including
coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and
customer agreement documents at a project, country and site level.
• Assists with quality control processes and translation processes related to submissions, contracts and
essential documents.
• Under supervision may assist in negotiations of budget and contracts with site and via Site Contracts
Service Center and SSUL with Sponsor until resolution of issues.
• Assists in the reviews of contracts for completeness and accuracy, and ensures that corrections are
appropriately made and documented.
• Assists SSU staff with the active project management of ongoing contract issues; performs follow-up
on all outstanding contract issues.
• May serve as communication liaison between site contracts staff and internal and external customers.
Provides functional guidance and keeps internal and external teams aware of all contract statuses or
pending issues. Prepares correspondence as necessary.
• Assists in providing and generating (amended) contract and/or budget documents as necessary,
preparing contract management documentation for projects, and streamlining the contract/proposal or
internal processes; initiates and introduces creative ideas and solutions.
• Arranges execution of CTAs as well as archival of documents into repositories and capture of
metadata.
• Provides support in preparation of Ethics Committee, Regulatory and any other relevant local
applications and submissions.
• May assist in ensuring compliance within the forecasted country/site timelines, helping to ensure
compliance with milestone progress in agreed upon SSU tracking system in real time.
• Facilitates the execution of contracts by company signatories.
• Supports the maintenance of contract and essential document templates and site-specific files and
databases.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract;
escalates discrepancies in a timely fashion.
• Reviews and complies with SOPs and Work Instructions (WIs) in a timely manner, keeps training
records updated accordingly and ensures timesheet compliance.

■休日：完全週休二日制, GW, 祝日, 年末年始, 土, 日

【JOB SUMMARY】
The position provides customer-focused leadership in managing operational and financial aspects of clinical trial supplies management during the complete project life cycle. Duties may include liaising with Customers, vendors and/or investigative sites to manage Clinical Trial Supplies deliverables.
Assignments may range in size and scope from single service to full scope and may include multiple studies. Accountable for successful execution of all assigned services, where success includes on time,on budget, high-quality/compliant deliverables that lead to satisfied customers.

【JOB RESPONSIBILITIES]】
Project Leadership and Delivery:
・Manages logistics of clinical trial supplies for assigned studies as an independent Clinical Trial Supplies Manager (CTSM); ensures compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), relevant standard operating procedures (SOPs), and regulatory requirements
・Ensure operational delivery and financial performance of services assigned to the CTSM team
・Identifies clinical trial supply vendors; manages contracting of preferred vendors, as required
・Provides vendor management, inclusive of ensuring key Clinical Trial Supplies deliverables are met
and financial parameters of contracts are upheld
・Defines supplies requirements in collaboration with client packaging and distribution vendors and the PL
・Works with the PL to obtain parameters and inputs to implement and maintain drug and supply distribution plans
・Directs activities of assigned Clinical Trial Supplies Associates (CTSAs); ensures proper resource levels to deliver work

Reporting and Communication:
・Accountable for maintenance of project information on a variety of databases and systems
・Oversees the inventory, supply, and re-supply plans for subject kits and/or study medication required for the duration of a study and provides relevant reports for customers and management
・Develops and implements project plans in accordance with Controlled Documents and ensures proper archival of records in Trial Master Files to ensure inspection readiness
・May prepare, coordinate, and present project material at internal and external meetings (e.g., internal team training meetings, Investigator meetings)
・Develops contingency planning and risk mitigation strategies to ensure successful provision of all required clinical trial supplies

Business Development
・May participate in bid defence meetings for new business opportunities to articulate capabilities of the CTSM team and proposed strategies for management of clinical trial supplies logistics
・Develops strong relationships with current and potential customers to ensure satisfaction and identify new business opportunities

■休日：完全週休二日制, 年末年始

【Essential Functions】
　•Project Administration - Acts as a primary liaison between the Company and the Customer to ensure study launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement. Coordinates project organization, implementation, and management activities between all Company operations and the client. Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. Oversees and tracks site payment issues as required. Alerts Finance on the need for Customer invoicing. Oversees the regulatory document collection and submission process. Ensures project documentation, including Trial Master Files are complete and audit ready. Assists in the negotiation and contracting process with outside vendors (labs, printers, etc). May perform or oversee site feasibility assessments. Reviews protocol, Case Report Forms and edits specifications for consistency within each document, cross-checking these documents against each other. Develops and maintains project plans for the study in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WI). Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports, and functional area plan to appropriate team members and senior management. Performs ongoing review of project financial status of studies. Alerts senior management to potential issues and ensures necessary corrective action is taken.
　•Communication - Independently prepares and presents study material at client meetings and communicates outcomes to project team at review meetings. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans.
　•Business Development - Develops strong relationships with current clients to generate new and/or add-on business for the future. Supports the Business Development department by participating in Customer proposal development as well as providing information on the Company's capabilities, patient populations, etc. May present Company capabilities as well as project management specific responsibilities at Customer proposal defense meetings.
　•Knowledge/Training – Demonstrates mastery of current therapeutic environment and drug development trends. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
　•Project Leadership - Manages a project as project manager. May manage more complex/larger global projects and/or programs. Acts as a liaison and facilitator between other departments within the Company to ensure project related tasks and/or issues are addressed.

■休日：完全週休二日制, GW, 祝日, 年末年始, 土, 夏季休暇, 日

医薬品の臨床開発におけるモニタリング業務を担当していただきます。
基本的にはグローバル治験（国際共同治験）が中心です。外資系製薬会社から受託しているプロジェクトの治験実施計画書に基づき業務を行っていただきます。

■具体的な仕事
・治験を実施する医療機関への治験依頼
・実施医療機関への治験依頼や医師の選定
・治験薬の交付
・症例報告書の回収及び点検
・治験の終了手続きなど
※出張は月に5～6回程度あります。

■休日：完全週休二日制, 祝日, 年末年始

クライアントから委託を受け、治験が適切な医療機関において
関連法規（GCP）や実施計画書（プロトコール）に従って実施されているか、また被験者の人権・安全が保護されているかを確認（モニタリング）する業務です。

治験を実施する医療機関と担当医の選定
治験スケジュールや契約内容の確認、医療機関のスタッフへの説明会の実施
治験の進捗管理： 症例数の進捗管理、症例報告書の回収・点検、症例報告書と資料との照合
治験薬の交付、供給管理状況の確認、回収
モニタリング報告書の作成
治験終了手続き、確認作業

■休日：完全週休二日制, 年末年始, 夏季休暇

・関連部署及び外部業者との調整、進捗及びスケジュール管理
・臨床開発関連文書作成 (試験実施計画書、同意説明文書、治験薬概要書等、治験総括報告書、CTD等)
・開発関連文書作成時のQC　等

■休日：完全週休二日制, 年末年始, 夏季休暇

■治験が適切な医療機関において、関連法規や実施計画書に従って実施されているか、また被験者の人権・安全が保護されているかをリモートで確認する業務です。
・治験を実施する医療機関と担当医の選定
・各施設における治験手続き業務（初回・変更・終了）全般
・エントリー進捗および症例スクリーニング状況の確認等の症例管理
・施設からのプロトコールや症例関連の問い合わせ対応、施設のEDC対応補助（クエリ対応など）
・モニタリングプランに基づいたサイトマネジメントコール
・治験届出内容（医師等の異動など）の確認
・システム関連のセットアップ
・モニタリング報告書の作成

■休日：完全週休二日制, 年末年始, 夏季休暇

国際共同開発プロジェクトの一員として、臨床開発モニタリング業務を一任します。

【具体的な業務】
◆実施医療機関の適正評価選択
◆実施計画についての合意確認等
◆治験のモニタリング（プロトコル説明・治験薬交付／管理）
◆治験薬回収
◆症例報告書（ＣＲＦ）の回収、ＣＲＦチェック）

【概要】
受託PJはグローバルが6割ですが今後益々増えていく予定です。

※英語力について
当面は必要ありませんが、社内システム、SOP等は全て英語表記です。御入社後に勉強していく姿勢が必要不可欠です。

■休日：完全週休二日制, 年末年始, 夏季休暇

仕事内容
GQP/GCP/QMS等に基づくグローバル臨床開発部門として
・TMFの管理体制構築・改善推進と管理（システム管理を含む）
・業務委託先のTMFオーバーサイト
・デジタル等を活用した業務効率化
・国内外Inspection対応

Description of work：
As a global clinical development function based on GQP/GCP/QMS, etc.
・Establishment, promotion of improvement and management of TMF management system (including computer system management)
・Oversight service provider's TMF
・Improvement of operational efficiency through the use of digital and other means
・Management of global clinical trial related contracts
・Global inspection

■休日：完全週休二日制, 年末年始

仕事内容
・レジストリ，電子カルテ等のデータを用いた臨床開発計画（CDP）立案に対する統計的・データサイエンス的側面からの助言
・デジタルデバイスや画像・自然言語処理を用いた前処理・解析の実施
・構造化/非構造化データに対する機械学習等による高度解析の実施
・海外カウンターパートとのコミュニケーション

Description of work：
It is better if you have the following experience and achievements:
・ Provide statistical input to planning clinical development plan by statistical and data science point of view using data of registries and EHR
・ Data processing and analysis using digital devices, images, and natural language
・ Advanced analytics (i.e. machine learning) using structured/unstructured data
・ Communicate with biostatistician in Roche/Genentech

■休日：完全週休二日制, GW, 祝日, 年末年始

■仕事内容：
中外オリジン開発プロジェクトのスタディリーダー
-臨床試験の計画および実行
-デジタルデバイス、新規システム等を活用した臨床試験の立案・実行
-期間内の症例数集積　
-CRO/Vendorオーバーサイト
-Patient Centric活動 等

■Description of work:
Study leader in Chugai-originated development project
-Planning and execution of clinical studies
-Planning and execution of clinical studies utilizing digital devices and new systems
-Completion of patient enrolment on schedule
-CRO/Vendor oversight
-Patient centric activities
etc.

■職種の魅力：
自社研究所で創製された⾰新的な新薬候補の価値を早期に証明する臨床開発計画をグローバルチームを統率して⽴案・実施することにより、世界の患者様に価値の高い新薬を届けることに貢献できます。

■Position Features：
You can contribute to the delivery of the high-value new drugs to patients around the world by planning and execution of clinical development plan, which can demonstrate the value of innovative new drug candidates created in in-house research labratory, while supervising global team.

■休日：完全週休二日制, GW, 年末年始

■仕事内容：
中外オリジン開発プロジェクトの臨床開発機能リーダー、サブリーダー
・適応疾患の検討およびbiological PoC試験のデザインを含む臨床開発計画（CDP）の⽴案
・開発段階に応じたTPP(Target Product Profile）の策定
・試験プロトコル骨⼦の作成
・海外カウンターパートや領域エキスパートなど国内外ステークホルダーとの交渉
・デジタル技術を活用した開発戦略の策定
・グローバルの臨床チームを統括して、早期臨床試験を推進する
・CRO/Vendorオーバーサイト

■Description of work:
Clinical leader/sub leader in Chugai-originated development project
・Investigation and planning of target indications and CDPs including the designs of biological PoC studies
・Setting target product profile (TPP)
・Creation of protocol synopsis
・Communication and negotiation with affiliates overseas and domestic stakeholders, such as therapeutic area experts (TAEs)
・Building a development strategy utilizing digital technology
・Promotion of early clinical studies by supervising global clinical team
・CRO/Vendor oversight

■職種の魅力：
自社研究所で創製された⾰新的な新薬候補の価値を早期に証明する臨床開発計画をグローバルチームを統率して⽴案・実施することにより、世界の患者様に価値の高い新薬を届けることに貢献できます。

■Position Features：
You can contribute to the delivery of the high-value new drugs to patients around the world by planning and execution of clinical development plan, which can demonstrate the value of innovative new drug candidates created in in-house research laboratory, while supervising global team.

■休日：完全週休二日制, GW, 祝日, 年末年始

【Purpose & Scope】
-Accountable and responsible for development and implementation of a global medical development plan on an early to late-phase project.
-Serves as global medical lead (GML) on early stage project or at the indication study level for a larger/complex/multi-indication program.
-Responsible for designing and conducting a global medical program resulting in quality regulatory submissions.
-Responsible for the medical interface with drug discovery, regulatory and commercial colleagues.
-Provides medical leadership on the Global Project Team and may chair the Global Clinical Team meetings; collaborates with other project team members and study team(s) to ensure delivery and quality of clinical trials.

【Essential Job Responsibilities】
-Fulfills the role of Global Medical Lead (GML) and is a member of the APGD Core Team.
-Responsible for design and recommendations of the clinical development plan(s), after soliciting appropriate input and review from Medical and Clinical Operations colleagues as well as other contributing line functions (Regulatory Affairs, Statistics. Clinical Operations, Commercial).
-Leads the medical team for assigned clinical trials to design, implement, conduct and interpret clinical studies to support decisions to advance or halt development of a new drug or to successful filing regulatory submissions.
-Responsible for execution and delivery of the clinical development plan.
-Acquires publicly available knowledge of competitor products and clinical plans.
-Negotiates milestones and ensures clinical development objectives are met.
-Motivates global clinical team towards the common goal of submissions of approvable regulatory filings or next clinical milestone.
-Attends important meetings with the FDA, PMDA and, as needed, with regulatory agencies worldwide.
-Contributes to Global Project Team meetings.
-Responsible for keeping GDPL, other project physicians and VP Global Medical Science TA Head informed of clinical progress and any critical clinical issues and especially the emerging safety profile.
-Contributes to clinical documents: protocols, IBs, study reports, statistical analysis plans, publications, CSRs and clinical sections of regulatory submissions.
-Responsible for clinical expert panel meetings and advisory boards to give input on clinical plans.
-Presents to senior management and external audiences on clinical aspects of compound development: including milestones, strategies, recent data.
-Incorporates Health Economics Outcomes Research requirements into protocol design.

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