Clinical Trial Associate

2週間前

Tokyo Astellas Pharma Inc. Permanent
Description

【募集の背景 / Purpose & Scope】

In Clinical Operations Oncology, we work with domestic and international co-development partners and overseas team members to develop clinical development strategies and clinical trial plans, and we are responsible for a wide range of tasks from executing clinical trials, collecting data, contributing new drug application (NDA), and discussing and obtaining approval from regulatory authorities. We are looking for new member who is interested in drug development in the oncology field and can boldly take on new challenges while working with overseas members.

・This position will assist the Clinical Trial Lead (s) and Clinical Trial Manager(s) in the day-to-day operations, set-up, execution, and close-out of assigned drug trials, for post-POC interventional drug trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).

・This position is accountable to the clinical trial team for the support of the trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables.

【職務の内容 / Essential Job Responsibilities】

(雇入れ直後)

・Supports the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

・Responsible for maintaining accurate and up-to-date trial information within relevant tracking systems and provide regular updates as requested to trial team and other defined stakeholders.

・Participates in or lead trial related systems set-up including implementation and maintenance of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data.

・Participates in feasibility assessment and selection of countries and sites for trial conduct.

・Participates in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team.

・Participates in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables.

・Ensures quality and completeness of TMF for assigned clinical trials.

・Participates in trial team meetings and manage associated documentation as requested.

・Participate in the coordination and implementation of patient-focused strategies for assigned trials, as applicable.

(変更の範囲)

会社内での全ての業務

【対象となる方 / Qualifications】

・BA/BS degree (Faculty of Pharmacy or Science is preferable) with at least 5 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience.

・A minimum of 2 years of clinical trial experience in Oncology area.

・Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.

・Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.

・Must have excellent interpersonal, written, and verbal communication skills, administrative skills, and computer ability.

・Fluent in English (e.g., TOEIC Score≧750 or an equivalent level)

・Experience working cross-functionally and in matrix teams.

・Experience of global study management including MRCT.

・Work experience to communicate/negotiate with Non-Japanese in English.

・Act with a challenging attitude without being bound by past precedents.

・Communicate well with medical professionals including KOLs and those involved in business outsourcing.

・Fully understand and comply with laws and regulations and compliance.

【職場環境 / Working Environment】

・This position is a hybrid position that allows flexible work as determined by the department or division. In addition, it has been basically recommended to work at office twice a week.

・Because of working with global team members, joining TC in early morning and/or late evening is sometimes required.

【勤務地/ Work Location】

(雇入れ直後)

東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo

(変更の範囲)

会社の定める事業場および自宅

  • Clinical Trial Associate

    17時間前

    Tokyo Astellas Pharma Inc. Permanent

    Description 【募集の背景 / Purpose & Scope】 · In Clinical Operations Oncology, we work with domestic and international co-development partners and overseas team members to develop clinical development strategies and clinical trial plans, and we are responsible for a wide range of tas ...

  • Initiation Clinical Research Associate II

    3日前

    Tokyo Parexel フルタイム

    When our values align, there's no limit to what we can achieve. · 職務内容サマリ■職務内容 · initiation Clinical Research Associate (iCRA)は主に施設選定後から、施設の立ち上げ完了となるまでの期 · 間で、治験施設立ち上げ担当者として初回申請に必要な文書の作成から申請手続きを専任で行います。 · iCRA が施設と直接コンタクトして申請手続き及び治験薬搬入準備を整え、立ち上げ終了時にモニター · (CRA)へ引継ぎます。その後の変更手続き等も ...

  • Clinical Research Associate

    13時間前

    Chiyoda Novo Nordisk

    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・治験前にデンマーク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・ノボノルディスクの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 ...

  • Clinical Research Associate/臨床開発モニター(東京・大阪・在宅可)

    13時間前

    Tokyo Parexel

    When our values align, there's no limit to what we can achieve. · 臨床開発モニターは、治験に参加くださる患者さんの人権・安全・福祉を保護しつつ、科学的に実効性のあるデータが得られるよう、関連法規や治験実施計画書に基づき、臨床試験の進行状況の確認や調査を行います。 · 具体的には以下のような業務を遂行します。 · •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(Good Clinical Practice)、治験実施計 ...

  • SSUスペシャリスト(臨床試験立上げスペシャリスト) /(Senior) Initiation Clinical Research Associate II

    6日前

    Tokyo Parexel フルタイム

    When our values align, there's no limit to what we can achieve. · ■職務内容 · initiation Clinical Research Associate (iCRA)は主に施設選定後から、施設の立ち上げ完了となるまでの期 · 間で、治験施設立ち上げ担当者として初回申請に必要な文書の作成から申請手続きを専任で行います。 · iCRA が施設と直接コンタクトして申請手続き及び治験薬搬入準備を整え、立ち上げ終了時にモニター · (CRA)へ引継ぎます。その後の変更手続き等も担当します。 ...

  • Japan Clinical Development Lead/ Associate Medical Director

    9時間前

    Tokyo Biogen Full time

    Job Description · The position takes a responsibility for medical contents in all clinical development programs in assigned therapeutic areas (such as dementia, movement disorders, neuromuscular, and MS/Immunology etc.) in Japan. The individual functions as a scientific and clin ...

  • Senior Manager, Medical Writing

    17時間前

    Tokyo Genmab

    ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。 · The Role: · We are looking for a highly motivated, independent and talented Medical Writing Manager/Senior Manager. In this role, you will be responsible for driving, developing, and writing clinical documents to support ...

  • Medical Scientific Liaison

    3日前

    Tokyo Abbott

    MAIN PURPOSE OF ROLE · • Specialist professional individual contributor with comprehensive knowledge in the area of Medical Affairs. · • Ability to execute highly complex or specialized projects. · • Adapts precedent and may make significant departures from traditional approache ...

  • Project Manager

    17時間前

    Tokyo Abbott

    General Summary: · Provides project management and leadership to plan, prepare and execute high-quality large scale and/or complex clinical program(s). Leads the clinical project team members toward the completion of deliverables in a timely fashion within an agreed project time ...

  • Manager or Staff, Submission Management and Publishing, Regulatory Operations, Japan Regulatory Affairs/ 薬事部 薬事オペレーションG SMPチーム 課長代理又は担当者

    13時間前

    Tokyo Takeda フルタイム

    Description · Please note this job requiresbusiness level Japanese in speaking, writing, and reading. · タケダの紹介 · タケダは「世界中の人々の健康と輝かしい未来に貢献する」ことを企業の存在意義(パーパス)としています。そして目指す未来を共有しながら、一人ひとりが自分の可能性を引き出し、お互いの個性を認め合う、多様性にあふれた先進的な組織作りに取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。 · ...

  • Associate Director, Medical Affairs – Kite

    13時間前

    Tokyo Gilead Sciences K.K. Full time

    Description · We are looking to recruit an Associate Director, Medical Affairs Strategy to join the Kite Medical Affairs team in Japan. The Kite Medical Strategy co-develops the Medical Affairs product and TA strategy and its tactical plan in collaboration with MSL and Medical S ...

  • Sr Manager~Associate Director, Medical Affairs – Kite

    13時間前

    Tokyo Gilead Sciences Regular

    Job Description · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therap ...

  • FSP Clinical Lead

    13時間前

    Tokyo IQVIA Full time

    Job Overview · Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of c ...

  • Clinical Team Lead

    3日前

    Tokyo TOK Fortrea Japan kk (Co., Ltd. in English) Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and techn ...

  • Head of Regulatory Affairs

    13時間前

    Shinjuku City Abbott

    Overview · Responsible for the management/strategy of Regulatory Affairs (RA) activities in Japan (supporting all of Abbott Rapid Diagnostics), including Key Opinion Leader (KOL) Advisory Board development and management. · Responsibilities · Is a key member of the local manag ...

  • Strategic Planning, Radio Technology

    13時間前

    Tokyo Rakuten Mobile Full time

    Description · : About Organization · The Radio Technology and Policy Department is responsible for radio policy, radio technology, and license management in cooperation with related departments within the company. In addition to the above, this department is also responsible f ...

  • Sr Spec/Mgr, Clinical Data Mgmt

    3日前

    Tokyo Edwards Lifesciences Full time

    Provides expertise on the Clinical Data Management activities. · Key Responsibilities: · • Plan and lead Data Management activities for multiple (multi-site and multi-cohort) projects for both clinical trials and PMS (Post Marketing Surveillance) with accountability for successfu ...

  • Sr Manager Drug Safety

    3日前

    Tokyo Regeneron Pharmaceuticals, Inc Full time

    We are looking for a Senior Drug Safety Manager with a strong background in GVP operational experience. This role will provide an opportunity to ensure our systems matter by updating procedures with our Japanese partners and working on local SOPs. We are a small yet multifaceted ...

  • Strategic Planning of radio policy and radio station license management, License Management Section

    7日前

    Tokyo Rakuten Mobile Full time

    Description · : About Organization · The Radio Technology and Policy Department is responsible for radio policy, radio technology, and license management in cooperation with related departments within the company. In addition to the above, this department is also responsible f ...

  • Business Development Associate

    17時間前

    Tokyo Thermo Fisher Scientific Full time

    : Build strong understanding of new customers and their marketplaces through a broad range of information sources, identify and lead new business opportunities with the customers. · Discovering new business opportunities and expanding market awareness of PSG's services. · Quali ...

  • Mgr, Market Access

    17時間前

    Tokyo Edwards Lifesciences Full time

    Role Purpose: This position will drive the execution of Market Access strategies specific to the Edwards' BU portfolio of innovative therapeutic solutions for structural heart disease and/or advanced critical care technologies in Japan. The successful candidate will drive synergi ...