製薬 × 臨床開発 の求人情報一覧
-
NEW求人番号：Job-00235715 掲載日：2023-09-22
CRA
global team700 - 900 万円 東京 製薬 臨床開発
- 会社概要
- 同社は世界最大手で総合的なラインアップを扱っている医薬品開発企業です。
- 業務内容
- 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 Labcorp 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 Labcorp 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 Labcorp 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 Labcorp 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
Emely Motol
Pharma -
NEW求人番号：Job-00209378 掲載日：2023-09-21
[Daiichi Sankyo] プロジェクトマネジメント
CROで開発業務5年以上かつプロジェクトマネジメント業務の経験をお持ちの方必見で700 - 1000 万円 東京 製薬 臨床開発
- 会社概要
- 同社は、大手製薬会社です。
- 業務内容
- 開発プロジェクトにおけるプロジェクトマネジメントとして、グローバルプロジェクトチームのマネジメント、開発戦略計画、予算、タイムラインおよび課題管理・解決をお任せいたします。
Patrick Chang
Pharma -
NEW求人番号：Job-00207918 掲載日：2023-09-21
Contracts Manager （グローバルメガファーマプロジェクト）
臨床試験立ち上げ業務のご経験が活かせます！800 - 1500 万円 東京 製薬 臨床開発
- 会社概要
- グローバルでのCRO市場において、トップレベルに位置付けられる医薬品開発業務受託機関の日本法人です。
- 業務内容
- リーガルの観点から臨床試験の施設契約、機密保持契約の内容が問題ないかレビュー、フィードバックをお任せいたします。
またCRAやContracts Associate対して、交渉ガイドライン、施設契約に関するトレーニングを実施いただきます。
臨床試験を実施するCROとの施設契約に関するレビュー、テンプレート内容の交渉
ガイドライン、日本の相場、適切なSOWに基づく医療機関向け治験費用の分析、および社内承認プロセスにおけるリード
Global CAチーム、Clinical Operationsチームとの連携および協働し、法的なリスクの評価
契約における修正条項やその可能性に関する見立て、および分析業務
契約締結、費用交渉に関するリードタイムの短縮化、効率的なオペレーションの検討
Patrick Chang
Pharma -
NEW求人番号：Job-00228535 掲載日：2023-09-21
データサイエンス職（非臨床研究の統計解析担当）
非臨床研究データの統計解析業務に従事されたご経験をお持ちの方必見です600 - 1000 万円 東京 製薬 臨床開発
- 会社概要
- 同社は、大手製薬会社です。
- 業務内容
- 多様な医療ニーズに応える医薬品を提供する同社で、データサイエンス職としてご活躍いただきます。非臨床研究の計画およびデータ解析に関するコンサルタント業務
非臨床研究データ解析システムの管理、利用者のサポート業務
非臨床研究者に対する統計教育
Patrick Chang
Pharma -
NEW求人番号：Job-00209417 掲載日：2023-09-21
臨床開発戦略・薬事コンサルタント<再生医療分野>
ニッチ分野で成長を続ける成長企業700 - 1000 万円 東京 製薬 臨床開発
- 会社概要
- 同社は創薬支援サービスを提供しています。
- 業務内容
- 再生医療分野における製品の上市を目的に、再生医療等製品(細胞加工、遺伝子治療)の開発に関する以下の業務を総合的に行う。開発戦略立案等に関するコンサルテーション業務
RS相談、治験相談支援
再生医療等製品臨床開発
再生医療等製品開発体制構築支援
Patrick Chang
Pharma -
NEW求人番号：Job-00228534 掲載日：2023-09-21
データサイエンス職（解析プログラミング担当）
プログラミング業務経験をお持ちの方必見です600 - 1000 万円 東京 製薬 臨床開発
- 会社概要
- 同社は、大手製薬会社です。
- 業務内容
- 多様な医療ニーズに応える医薬品を提供する同社で、データサイエンス職としてご活躍いただきます。CDISC標準に準拠したSDTM／ADaMデータセット仕様ならびに関連資料（define .xml, Reviewer’s Guide等）の作成
試験中のデータレビュー用プログラム仕様作成、構築
統計解析計画書を基にした帳票・グラフおよび解析プログラムの仕様作成
承認申請時に必要な電子データの作成ならびに規制当局対応
Patrick Chang
Pharma -
NEW求人番号：Job-00219551 掲載日：2023-09-20
CRA
CRA in Pharma600 - 1150 万円 東京 製薬 臨床開発
- 会社概要
- 世界的なヘルスケア企業です。
- 業務内容
- 1.治験準備と治験実施計画書の合意症例の集積性や治験実施計画書の内容より、適切な医療機関と治験責任医師を調査
医療機関側と治験実施計画書についての説明/合意、治験審査委員会への書類提出、治験開始準備
治験前に本社スタッフとのミーティング(オンライン/対面)に参加
2.治験開始時・実施時の施設管理SOP を含む手順書や治験実施計画書、ICH/J-GCP、その他の適用される法規制に沿ったモニタリング関連業務の実施
治験審査委員会への治験申請契約
治験薬搬入
安全性情報の提供
被験者のリクルート
治験データの質の維持を目的としたRisk based monitoring(RBM)の実施
担当領域トレーニングへの参加及び施設スタッフとの勉強会
医師との関係構築
自身のアイディアで様々な問題を解決
3.監査・査察海外の監査員からの監査を受ける
FDA/EMA 査察の準備・対応
PMDA 査察の準備・対応
4.その他本社スタッフや各リージョンスタッフと連携しグローバルタスクに参加
業界団体 (例EFPIA:欧州製薬団体連合会)の会合に参加
ラインマネージャーのサポート
治験実施計画書のレビュー
Emely Motol
Pharma -
NEW求人番号：Job-00242114 掲載日：2023-09-20
CRA
rich pipeline800 - 1000 万円 東京 製薬 臨床開発
- 会社概要
- 海外に本社を構えるバイオ医薬品企業です。
- 業務内容
- Monitors activities conducted by clinical investigative sites as they relate to their clinical studies to ensure successful execution of the protocol.
Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, their Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and their Standard Operating Procedures (SOPs) and business processes.
Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance.
Ensures regulatory inspection readiness at assigned clinical sites.
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow up for all safety events by site personnel.
Ensures safety and protection of study subjects through compliance with the study monitoring plan, their SOPs, ICH Guidelines, and applicable regulations.
Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
Manages investigator payments as per executed contract obligations.
Negotiates investigator/ hospital agreements with stakeholders.
Maintain and complete own expense reports as per local and applicable guidelines.
Identifies, evaluates and recommends new/potential investigators/sites on an on going basis.
Potential sites may be identified through networking or internal requests to assist in the placement of planned clinical studies with qualified investigators.
Emely Motol
Pharma -
NEW求人番号：Job-00229259 掲載日：2023-09-20
Regulatory Submissions Coordinator (SSU)
Foreign-affiliated CRO320 - 750 万円 東京 製薬 臨床開発
- 会社概要
- 同社は顧客企業の医薬品や医療機器の支援者として顧客企業に代わって治験を実施しています。
- 業務内容
- Distribute, track, review, and approve individual site Trial Master File (TMF) essential documentation at project start;
Collect, review, organize, and assemble regulatory start-up submissions;
Maintain timelines for regulatory submissions and site start-up;
Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
Review pertinent regulations and guidance to develop proactive solutions to regulatory submissions issues and challenges;
Utilize and assist in maintaining ClinTrak® (e.g., Essential Documents module);
Work with Document Center to ensure necessary documentation is present; and
Train and assist Clinical Research Associates on collection of essential documentation for on-going phase of project. Review documentation submitted by Clinical Research Associates and forward to client/Document Center.
Emely Motol
Pharma -
NEW求人番号：Job-00229255 掲載日：2023-09-20
Safety Coordinator/Manager
Foreign-affiliated CRO350 - 760 万円 東京 製薬 臨床開発
- 会社概要
- 同社は顧客企業の医薬品や医療機器の支援者として顧客企業に代わって治験を実施しています。
- 業務内容
- Determine plan of action for incoming calls;
Collect, process, and track incoming events;
Write safety narratives;
Report on various safety data; and
Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes.
Emely Motol
Pharma -
求人番号：Job-00254782 掲載日：2023-09-18
Manager/Sr. Manager Product Communications, CSR and Advocacy
career growth to line mngmt1000 - 1600 万円 東京 製薬 臨床開発
- 会社概要
- 同社はグローバル規模の医薬品・臨床研究の企業です。
- 業務内容
- Develop and implement product-related external/internal communications plans/campaigns aligned with brand strategies, while identifying communication opportunities and threats in the external environment and incorporate them into the plan appropriately. Plan/implementation includes the followings.
- Development of PR materials- e.g. press release, standby statement, factbook, Facebook contents, etc.
- Issuing press release (including the translation of global press release)
- Handling media inquiries
- Event implementation- e.g. press seminar, public seminar, CSR activity, etc.
- Communication and collaboration with alliance partners (as needed)
- Crisis communication
Identify and prioritize patient advocacy groups for each therapeutic area to work with and develop/maintain relationships and partnerships with selected groups as appropriate.
Emely Motol
Pharma -
求人番号：Job-00228820 掲載日：2023-09-13
【東京】Manager of Clinical Operations
CRO における臨床試験経験者必見です!800 - 1500 万円 東京 製薬 臨床開発
- 会社概要
- 臨床試験における総合的な業務をフルサービスで提供する開発業務受託機関です。
- 業務内容
- 経験の浅いCRAおよびIn-houseCRAの教育・指導を行う
クライアントおよび同社のKPI、システム、プロセスに照らし合わせ、メンバーのパフォーマンスやコンプライアンス順守を確認・評価する
CRAおよびIn-houseCRAといったメンバーが、クライアントにて高いパフォーマンスを発揮し、質の高い業務を行えるようなマネジメント、およびキャリア開発プランに基づく育成を行う
メンバー個人のキャリアゴールの達成に向けたサポートや、適切なフィードバックを行う
昇給、昇格に紐づくパフォーマンスのマネジメントを行う
優秀な人材の定着（retention）、およびクライアントの求める期待以上のサービスを提供できるように、メンバーの業務負荷に気を配りながらマネジメントを行う
クライアントのfunctionalmanagersとのコミュニケーションを取りながら、最適なメンバーマネジメントを行う
タスクフォースチームをリードし、仕組みやプロセス構築・改善に向けたイニシアティブを執る
自社メンバーのpointofescalationとして、問題やconflictの改善・解決に取り組む
必要に応じてassessmentvisitや、Auditに関するサポートを行う
パフォーマンスを最大限発揮し、クライアントに対して質の高いサービスを提供できるよう、FSPビジネスのクリニカルオペレーションに関わる人材の採用にも携わる
Patrick Chang
Pharma -
求人番号：Job-00229256 掲載日：2023-09-12
Project Coordinator
Foreign-Affiliated CRO450 - 720 万円 東京 製薬 臨床開発
- 会社概要
- 同社は顧客企業の医薬品や医療機器の支援者として顧客企業に代わって治験を実施しています。
- 業務内容
- Engage in clinical trial management on a day-to-day level. Communicate and coordinate study activities between the study Sponsor, site research coordinators, and study investigators, working closely with the Clinical Trial Manager (CTM), Clinical Research Associates (CRAs), and functional area leads as required. Collaborate with clinical study team members to support needs of the sites, and work to meet goals and timelines of clinical study Sponsor;
Maintain effective and efficient Sponsor communication, identify and anticipate possible issues or challenges, and work with the study team to develop appropriate solutions;
Adhere to Organization/Sponsor Standard Operating Procedures (SOPs);
Schedule study related meetings and trainings, tracking and reporting study metrics, and performing study close-out activities;
Perform feasibility and study start-up activities in collaboration with the CTM, functional area colleagues, and appropriate country contacts to ensure timelines are met;
Demonstrate comprehensive knowledge of GCP/ICH Guidelines, or any other applicable regulatory requirements;
Maintain close collaboration, interaction, and effective working relationships with CTMs, CRAs, and functional area colleagues;
Work with Information Design, Patient Recruitment and Retention (when applicable), and Regulatory Submissions on study supplies to ensure all supplies are IRB/EC approved and ready for distribution to sites;
Maintain ClinTrakSM study portal;
Prepare presentation materials for meetings such as the Kick-Off Meeting, Investigator Meeting, and any other face-fact sponsor meetings;
Create and maintain project timelines in Microsoft® Project and enrollment projections in ClinTrakSM;
Work with the Document Center and functional area colleagues to ensure all necessary project documents are present in the Trial Master File;
Perform Trial Master File Quality Reviews as defined by SOPs;
Maintain and track study supply inventory for study sites and coordinate shipping efforts of study materials;
Distribute study updates/correspondence to Sponsor, site, and company project team;
Schedule project team meetings (internal and external), be active participant, and distribute agendas, meeting minutes and action items to all team members, the Sponsor and vendors; and
Provide insightful input on project-related documents.
Emely Motol
Pharma -
求人番号：Job-00229260 掲載日：2023-09-07
Clinical Trial Manager
Foreign-Affiliated CRO980 - 1900 万円 東京 製薬 臨床開発
- 会社概要
- 同社は顧客企業の医薬品や医療機器の支援者として顧客企業に代わって治験を実施しています。
- 業務内容
- 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 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 Contract Manager.
Provide input for following (when applicable):
Study protocol
Edit Check Specifications
Data Analysis Plan
Data clean-up results
Analysis
Final study report
Emely Motol
Pharma -
求人番号：Job-00210948 掲載日：2023-08-18
Clinical Project Manager / Clinical Leader
Global Trail and high salary850 - 1700 万円 東京 製薬 臨床開発
- 会社概要
- 同社は、グローバルヘルスケアカンパニーです。
- 業務内容
- Manage Clinical Trials
Patrick Chang
Pharma -
求人番号：Job-00220681 掲載日：2023-08-16
Inexperienced CRA
Inexperienced450 - 650 万円 東京 製薬 臨床開発
- 会社概要
- 同社は臨床試験の受託開発・運営において世界トップクラスの企業です。臨床試験のあらゆる段階を支援するサービスを提供しており、独自の技術やノウハウを活用したバイオテクノロジー関連の臨床試験などのサービスも提供しています。
- 業務内容
- 治験を実施する医療機関や医師の選定
治験の依頼・契約
治験薬の搬入及び回収
モニタリング
GCP、治験実施計画書、SOP に則って治験が進んでいるかを確認
直接閲覧（SDV)を実施し、症例報告書とカルテ等が一致しているかを照合し、回収
IRB（治験審査委員会）への文書提出及び手続き
医療機関における保管必須文書が適切に保管されているか確認
モニタリング報告書作成
治験の終了手続き 等
Martin Tsvetkov
Pharma -
求人番号：Job-00251685 掲載日：2023-07-25
Senior Manager, Clinical Operations (Full Service)
Global CRO800 - 1300 万円 東京 製薬 臨床開発
- 会社概要
- 同社は世界最大手で総合的なラインアップを扱っている医薬品開発企業です。
- 業務内容
- Responsible for the supervision of assigned direct reports
Responsible for detailed performance review and management of assigned direct reports including: Annual Performance Management and Development (PMD), Individual Development Plan (IDP), Line of Sight Goals and “Shoves & Tugs”
Responsible for appropriate management and resolution of performance issues
Measure performance indicators for assigned staff within Clinical Operations.
Identify individual training needs and assist in the conduct of training and development efforts, regionally
Conduct on-site Accompanied Field Visit activities (Evaluation and Quality Control Visits) for Clinical Operations staff
Effectively communicate management strategies, policies and procedures in conjunction with leadership teams
Develop and maintain effective relationships with management team to manage Clinical Operations staff in a matrix environment.
Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.
GCP Oversight Accountability:
Has GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented.
Identify and escalate GCP issues identified through regular interactions with direct reports and conduct of Accompanied Field Visits
Ensures training record compliance with training matrix and ensures training records are up to date
Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff.
Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins
Hold Clinical Operations staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate.
Hold Clinical Operations staff accountable for compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables
Coach Clinical Operations staff to own effective Investigator relations and Investigator oversight at the local level.
Productivity/Financial Management:
Communicate status of assigned workload for metric reporting
Perform weekly review of direct report billable hours and associated utilization per the quarterly and annual budget plan, and escalation of outliers to management team for mitigation
Escalates available workload hours, in context of project allocation, supply and demand, to management team
Adheres to global tools for monitoring and utilization forecasting
Engage in Resource management activities for direct reports
Assist with staff recruitment through screening and interviewing
Financial authority in accordance with current signature approval matrix
Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports
Liaise with internal and external customers in relevant process improvement initiatives, including Six Sigma
Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
Schedule Accompanied Field Visits to ensure costs are in alignment with regional budget.
Emely Motol
Pharma -
求人番号：Job-00239726 掲載日：2023-07-14
Project Manager I or II
Top company1000 - 1500 万円 東京 製薬 臨床開発
- 会社概要
- 海外に本社を構えるバイオ医薬品企業です。
- 業務内容
- [PM I-II]
Project Execution & Cross Functional Collaboration:
Serve as a core member of JPT and coordinates JPT activities and deliverables.
Arrange JPT meetings and actively contributes to cross-functional JPT discussions both from a PM functional perspective and a cross-functional strategic perspective.
Lead cross-functional communications, involving relevant functions including the stakeholder outside JPT when necessary.
Support and navigate JPTs for collaboration and effective interactions between JPT and stakeholders/governance.
In partnership with JPTL (Japan Product Team Leader), drive cross-functional team effectiveness in JPT and foster JPT to become high performing team.
Project Planning and Analytics:
In partnership with JPTL, coordinate in creating a robust project development plan in alignment with the global asset strategy, having a consensus in the JPT. When necessary, accountable to compile and provide information necessary in JPT’s making most appropriate decisions.
Track the project plan and execution, having the principal accountability for and leading JPT activities on
- Monitoring the project progress/timeline and ensure accurate, up-to-date Japan timelines and reporting, focusing on key milestones and critical paths.
- Obtaining a governance budget approval for Japan part of projects in collaboration with PPM/PM in global teams, and monitoring budget status through LBE process (Latest Best Estimate) in collaboration with global finance (Senior Finance Analyst) and relevant functions in JD.
- Proactive risk management for each project, including risk mitigation and contingency planning.
- Issue identification and solution.
Cross-project/Strategic Portfolio:
Support for cross-project/portfolio discussions and reporting by providing necessary information on responsible projects.
[PM II]
Operational Excellence:
Driving project-management related initiatives or advancement strategies for project success within JD or their organization, to increase productivity and to be the best in class R&D organization.
People development:
Conduct training and coaching to junior PMs and contribute in building talent pipeline in PMG.
Emely Motol
Pharma -
求人番号：Job-00251686 掲載日：2023-07-13
CRA1 / 2 / Sr CRA - Full service/FSP
Global CRO500 - 900 万円 東京 製薬 臨床開発
- 会社概要
- 同社は世界最大手で総合的なラインアップを扱っている医薬品開発企業です。
- 業務内容
- Assures the implementation of project plans as assigned
Site administration and Site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
Act in the project role of as Local project Coordinator or Lead CRA as assigned
Emely Motol
Pharma -
求人番号：Job-00251682 掲載日：2023-07-13
Associate Manager, Clinical Operations (Full Service)
Global CRO800 - 900 万円 東京 製薬 臨床開発
- 会社概要
- 同社は世界最大手で総合的なラインアップを扱っている医薬品開発企業です。
- 業務内容
- Has regulatory oversight of direct reports by ensuring regulatory training is executed, understood and implemented
Escalate issues and follow them till proper resolution
Ensures training record compliance with training matrix and ensures training records are up to date
Provide input to relevant SOPs and standard plans/templates when applicable
Assist with coordination and implementation of on-boarding of new direct reports ensuring training before study-related activities begins
Hold staff accountable for issue escalation to the management team, the sponsor and QA, as appropriate and determine regional implications for corrective action plans
Hold staff accountable for quality and compliance with project plan and adherence to contract obligations
Coach staff to own effective Investigator relations and Investigator oversight when applicable
Report status of assigned workload of direct reports and ensure allocation reports are updated
Perform weekly review of direct report billable hours and utilization (in context of project allocation, supply and demand); escalate of outliers and assists management team for mitigation
Adheres to expectations for monitoring and utilization forecasting
Assist with staff recruitment through screening and interviewing
Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports
Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
Support the company/department processes (e.g. Quality Control Visits)
Responsible for staff time management, PTO and salary reviews
Might be requested to work in a client facing environment
Perform other duties as required by Management
Emely Motol
Pharma