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Latest Jobs

5 listing(s) available.

  • 25 Feb 2019

    経験CRA(医薬品・医療機器)

    Japan

    Permanent Position
    IQVIA - ヘルスケアの発展に寄与する医療情報、テクノロジー、分析力および人知による創意工夫を活用した幅広いソリューションを提供しています。日本法人として当社は唯一無二の医療データベースと最先端のテクノロジーをもとに、エビデンスに基づくインサイトを結集して、医療ステークホルダーの課題解決に寄与し、医療の発展と最適化に貢献します。

    Job Description

    <担当業務>
    製薬メーカー・医療機器メーカー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する。

    Expires on 12 Jun 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    <必須>
    ・CRA経験1年以上(GCP下での臨床試験の経験)
    ・単独で施設訪問ができる 
     

    【歓迎(WANT)】

    <経験があれば尚可>
    ・グローバル試験の経験
    ・大学病院やがんセンター等の担当経験
    ・監査又は実施調査の経験必須
    ・リーダー経験あり(若手の指導・育成) 

    給与は前職考慮の上で決定いたします

  • 18 Feb 2019

    Senior CRA

    Japan

    Permanent Position
    ICON - 世界でも5本の指に入るほどの規模と実績を誇るCRO。世界23ヶ国に拠点を持ち、約3600名の社員を抱え、その日本法人である当社は海外オフィスと協力し、海外での治験データを活用して日本での治験を簡略化させる今注目の「ブリッジング」や「グローバル試験」を実践。効率的な治験の実施に向け、戦略的に取り組む製薬メーカー様より大きな信頼を得ています。

    Job Description

    Role Responsibility
    1.Working within a highly qualified team you will identify, select, initiate and close-out investigational sites for clinical studies in phases II – III ensuring that applicable regulations and principles of ICG-GCP are adhered to 

    2.Working independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation 

    3.Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested 

    4.Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required 

    5.Managing sponsor generated queries efficiently and responsible for study cost effectiveness 

    6.Dependent on level of experience you may assist in training and mentoring less experienced CRA’s and/or manage CRA’s working on international projects

    Expires on 12 Jun 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    Experience and Qualification 
    1.1+ years of monitoring experience in phase I~III trials as a CRA 
    2.Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data 
    3.Native Japanese level and conversational English at least 
    4.Excellent communication and interpersonal skills, both written and verbal enabling you to deal 

    給与は前職考慮の上で決定いたします

  • 15 Feb 2019

    【第二新卒】Associate CRA

    Japan

    Permanent Position
    IQVIA - ヘルスケアの発展に寄与する医療情報、テクノロジー、分析力および人知による創意工夫を活用した幅広いソリューションを提供しています。日本法人として当社は唯一無二の医療データベースと最先端のテクノロジーをもとに、エビデンスに基づくインサイトを結集して、医療ステークホルダーの課題解決に寄与し、医療の発展と最適化に貢献します。

    Job Description

    ■担当業務

    製薬メーカー・医療機器メーカー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モニタリング業務を実施する。

    Expires on 12 Jun 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    2016年4月~2018年4月の間に新卒採用でCRO・製薬企業に入社しCRA業務に従事されている方 

    給与は前職考慮の上で決定いたします

  • 13 Feb 2019

    Sr CRA I CNS

    Japan

    Permanent Position
    Syneos - Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.

    Job Description

    Summary:

    Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while developing mastery and a thorough understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. Provides clinical and technical support for Clinical Research Associates (CRA) I and II and administrative staff. Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.

    Essential Functions:
    Communication - Maintains timely and effective communication among team members and site staff. Routinely anticipates/identifies potential issues and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution.
    Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations (CFR)/ International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested. Responds to less complex findings without oversight and may require guidance to respond to more complex/serious findings. May be responsible for submission of regulatory packages to ethics committees and/or competent authorities.
    Monitoring - Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits effective time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits.
    Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Proficient with multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed.
    Reporting and Tracking - Completes and submits reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
    Administrative - Prepares for and attends Investigator meetings. May attend Customer and Business Development meetings. May present materials, as requested. Assists with the preparation of study start-up materials and tools, as requested. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans.
    Other Responsibilities:

    May assume role as local or regional Lead CRA and/or assist with LCRA activities, e.g. tool development, study plans, and team training. Performs other work-related duties as assigned. Extensive travel may be required (more than 50%).
    Expires on 12 Jun 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience. Moderate clinical research and independent field monitoring experience. Thorough understanding of SOPs, WI, FDA, and local regulations as well as ICH GCP guidelines and an intermediate understanding and application of applicable therapeutic standards. Strong organizational, documentation, presentation, and interpersonal skills as well as a willingness to work within a team-oriented environment. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Effective command of written and spoken local language, if not English, as well as English. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Must have valid, current driver's license and ability to secure corporate credit card. ACRP CCRA or equivalent certification/credentials strongly preferred.
  • 18 Dec 2018

    Clinical Research Associate

    Japan

    Permanent Position
    Abbvie - アッヴィの歴史は医薬品業界の先駆者的存在である米国アボット社から始まりました。 アボット社は1888年、シカゴの医師Dr. Wallace Abbottによって設立されました。 以来、アボット社は、150ヵ国以上で革新的な医薬品、栄養製品、診断用製品および医療用製品を人々に提供しながら、医療界のグローバルリーダーとして進化しています。

    Job Description

    Major Responsibilities:

    • Monitors activities conducted by clinical investigative sites as they relate to clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.

    • The Site Clinical Research Associate (SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites.

    Expires on 12 Jun 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    Qualifications
    Essential Skills & Abilities:
    • Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring.
    • Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.

    • Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.

    • Experience in on-site monitoring of investigational drug or device trials is required.



    Education/Experience Required:

    • Bachelor’s Degree or equivalent knowledge required; medical/science/nursing background is preferred. 

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