Location: Tokyo, Tokyo JP Randstad Sourceright

Job Number:

External Description:

JOB TITLE: Clical Resarch Specialiset
DEPARTMENT: Clinical Research and Medical Science   Clinical Solutions  Study Monitoring
REPORTING TO: Clinical Research Manager

**********************************************************************************************

職務内容

募集職種: 臨床研究スペシャリスト(モニター職)

勤務地と勤務形態:

  • 勤務地: 東京 (ただし、担当施設の対象は全国)
  • 勤務形態: 出勤と在宅勤務のハイブリッド (募集開始時点の最低出勤回数:1回/月。今後増える可能性あり)

雇用形態: 正社員

仕事内容:

  • 治験、市販後臨床研究および市販後調査の計画・実施・進捗管理と報告書作成
  • 担当施設における手続き業務、モニタリングらびに監査対応
  • 関連文書の作成および確認
  • 内部・外部関係者との良好な関係構築
  • 重篤有害事象や逸脱の報告と対応
  • 医療機器の不具合報告と対応
  • その他、組織やプロジェクトに必要な業務

応募資格: 

<必須要件>

  • 大学卒業以上(医学、薬学、看護学、生命科学、工学関連分野が望ましい)
  • 医療機器会社、製薬会社、またはCROでの5年以上の治験モニター経験
  • 大学病院等の基幹病院の担当経験
  • GCPに関する深い知識
  • 高いコンプライアンス意識と品質意識
  • 優れたコミュニケーション能力と問題解決スキル
  • 自発的に考え能動的に行動できる能力
  • チームワークを重視し、協力して業務を遂行できる能力
  • 積極的に学び続ける姿勢
  • 以下に支障がないこと:
    • 重篤有害事象発生等への迅速な対応や突発的な外勤
    • グローバル会議への早朝あるいは夜間参加
    • 宿泊を伴う出張
    • 英語でのSOPや業務関連文書の読解、モニタリング報告書作成

<歓迎要件>

  • 循環器や心臓血管領域の担当経験
  • ISO 14155の知識
  • チームリーダーの経験
  • 新人やジュニアモニターの育成経験

給与: 当社規定に従って支給

昇給および賞与: 1回/年、会社業績および本人の業績評価をもとに支給

選考プロセス: 書類選考、対面またはリモートによる面接(2-3回)

Job Number:

Community / Marketing Title:
Clinical Research Specialist【 CRA 】

Location_formattedLocationLong:
Tokyo, Tokyo JP



  • Location: Tokyo, Tokyo JP Randstad Sourceright

    T ítemple de investigación clínica especializado. · El trabajador realizará planificación y ejecución de investigaciones clínicas, incluyendo la creación de informes. · ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright ¥2,000,000 - ¥3,000,000 per year

    透析治療のアクセスデバイスを扱うチームにて、臨床の知見から国内組織のマーケティング戦略策定及び実行を行う。取り扱う製品、治療方法、診断等について、医師、看護師、ME、代理店に対する情報提供 · 社ミッション及び企業方針、部門営業戦略の理解と実践 · 臨床的知見から製品プロモーションのための効果的な販売資料 · ,学術情報،販売トレーニングの作成と提供 · ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright

    顧客からの問合対応/営業サポート/受発注処理/納期管理に渡る一連のビジネスフローのオペレーション · 同時に担当領域における業務効率化・デジタル化プロジェクトの企画および実行 · ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright

    製品の安全かつ効果的な使用と臨床転帰の向上を目的とした、臨床、トレーニング、教育関連の活動を日本全国で実施 · ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright

    Technical leading regulatory compliance management for Beauty products in Japan: · - Engaging in global projects for regulatory affairs digital transformation and support Japan I&S to develop regulatory compliance guideline in line with global digital transformation · Evaluati ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright

    A clinical project manager is accountable for the delivery of patient-centric studies from protocol design through to study report and archiving. They work with internal and external stakeholders to ensure assigned studies are delivered according to contract specifications, with ...

  • MSL Oncology

    1週間前


    Location: Tokyo, Tokyo JP Randstad Sourceright $100,000 - $120,000 per year

    This MSL Oncology role will provide expertise on scientific topics regarding relevant disease areas and Company assets to ensure their safe and appropriate use by patients. · ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright

    The Cell Therapy Scheduling and Logistics Specialist I will be responsible for scheduling and monitoring patient treatment schedules for the manufacturing of Celgene's autologous cellular immunotherapy products. · ...

  • Market Researcher

    1週間前


    Location: Tokyo, Tokyo JP Randstad Sourceright $80,000 - $120,000 per year

    This position would be the go-to research specialist who can provide necessary guidance and insight for primary research as well as some secondary research, · Be nimble at providing actionable consumer/customer and media insight · Conduct and/or oversee a variety of primary quant ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright

    The Medical Education Specialist will drive regional medical education strategy and digital transformation providing guidance for the safe and effective implementation of S&N products technology across the country assigned franchise. · ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright

    This position includes both strategic and operational elements and requires communication skills as we work as a team to generate leads, execute campaigns, promote brands, drive future growth initiatives, and improve processes. · ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright ¥8,000,000 - ¥12,000,000 per year

    The GCDSE provides clinical and R&D expertise in regional/country context. They lead global project teams, provide medical guidance on safety protocols, interact with regulatory authorities, · and contribute to scientific publications. · Physician training in Pediatrics or Intern ...

  • Medical Writer

    3日前


    Location: Tokyo, Tokyo JP Randstad Sourceright ¥50,000 - ¥100,000 per year

    Create high-quality regulatory-compliant clinical documents supporting product life cycle under supervision Ensure timely delivery while maintaining compliance with company SOPs and guidelines Learn and adopt new digital technologies AI solutions and efficient processes Prepare c ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright ¥8,640,000 - ¥10,560,000 per year

    To deliver the above you will project manage multiple concurrent full-cycle implementations of Touch Surgery Ecosystem at major hospital systems ensuring projects are executed on-time and within budget. · Project manage multiple concurrent full-cycle implementations of Touch Surg ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright ¥4,000,000 - ¥8,000,000 per year

    Supporting identification and collection of competitive technical product information · Providing market-specific claims, merchandising information, and Distributor selling points, demos, and practices for current generation benchmark products. · ...

  • Pricing Strategist

    1週間前


    Location: Tokyo, Tokyo JP Randstad Sourceright

    Japan represents an important country for UCB's sales growth, with significant opportunity for UCB's rich pipeline of products. · The Pricing Strategist will achieve UCB's Pricing & Access objectives for the pipeline portfolio (with focus on BKZ, rare diseases, Briviact and Stacc ...


  • Location: Tokyo, Tokyo JP Randstad Sourceright

    Oversight of team quality in insight generation, advanced analytics and performance management. · ...

  • Digital Project

    1週間前


    Location: Tokyo, Tokyo JP Randstad Sourceright

    We are looking for a qualified Digital project manager to join our team. · ...

  • Specialist MKT-I

    1週間前


    Location: Tokyo, Tokyo JP Randstad Sourceright

    Support Brands Orchestrating and maximization Portfolio Impact Lead to provide Sales performance report/ Perform create data and analyze it. Support Marketing Portfolio Planning team's project Lead Business KPI management Support Commercial Innovation initiatives Support Chief Ma ...

  • MSL Fertility

    20時間前


    Location: Tokyo, Tokyo JP Randstad Sourceright ¥5,000 - ¥15,000 per year

    Provides scientific expertise on relevant disease areas ensuring safe use of Company assets by patients. · ...

  • MSL Fertility

    1日前


    Location: Tokyo, Tokyo JP Randstad Sourceright

    This role provides expertise on scientific topics regarding relevant disease areas and Company assets to ensure their safe and appropriate use by patients. The Medical Science Liaison collaborates with internal and external stakeholders to translate scientific data and medical in ...