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33 listing(s) available.

  • 12 Mar 2019

    RWES/ クリニカル・プロジェクト・マネージャー

    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

    <仕事内容>
    ・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
    ・施設選定時の判断と登録管理
    ・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

    <アピールポイント>

    ・疾患の疫学、既に承認された薬剤の観察研究などが業務の対象となります。試験結果は主に科学雑誌などに発表され、新しい治療法、患者さんの満足度向上に反映されます。

    ・臨床研究法の施行により研究の実施環境が整備され、CROとしての役割も大きくなることが期待されています。

    ・医師主導治験では医師との研究に関する議論の場も多く、自身の成長の機会が多くあります。

    ・業務に必要な英語、疾患知識の向上のために、全社で教育、研修に投資をしており、部門としても海外研修、国内学会への参加も推奨しています。

    Expires on 13 Apr 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>
    下記、いずれかのご経験
    ・臨床開発あるいは市販後試験の、プロジェクトマネジメントあるいはクリニカルトライアルリーダーの経験
    ・Medical Affairsにおける市販後試験、疫学研究の管理の経験 

    給与は前職考慮の上で決定いたします

  • 05 Mar 2019

    Clinical Project Manager

    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

    Description - External
    •Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Facilitate planning of operational aspects of clinical trials (startup, conduct, closedown) for Therapeutic Areas with respect to the study timing and resource needs.
    •Input and maintain study timelines and resources in PBR, ensuring consistency with IMPACT and the clinical development plans of the Therapeutic Area.
    •Provide analysis of predicted resource needs versus assigned HC and available
    •Supports clinical teams by providing metrics and guidance with respect to operational aspects of clinical trial timelines, resources,and logistics.
    •Works under minimal supervision in day-to-day activities and receives general guidance for ad hoc tasks. Effectively manages unexpected changes in workload and seeks guidance as appropriate.
    •Interacts with various levels of management and functions within organization, including but not limited to Global Project Teams, Finance, and Development Operations.

    Expires on 13 Apr 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)】

    Minimum Education:BS or BA or equivalent knowledge
    •Minimum 6 years of experience in pharmaceutical industry and minimum 4 years direct clinical research experience. Expertise in MS Office applications including Excel, Word, and Powerpoint. Experience with MS Project preferred. Candidates should be able to work with minimal supervision and have excellent analytical, organizational, and interpersonal skil


    給与:前職考慮のうえ決定します

  • 05 Mar 2019

    医薬開発本部CRAサイトマネジメント/CRA Site Management COJ Medicine

    Japan

    Permanent Position
    ベーリンガー・インゲルハイム - 全世界に145の関連会社と、約50,000人の社員を擁しています。 世界で3つの主要な研究開発拠点と、サポート拠点(日本)を持つ研究開発主導型企業として、グローバルに創薬活動を展開しています。

    Job Description

    Basic purpose of the job

    As a member of trial team, provide and maintain oversight and guidance related to site monitoring activities throughout the course of a trial, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, ICH-GCP and applicable regulations and ensure inspection readiness at all times.

    Provide operational expertise to the trial team on the site monitoring approach for the trial. Oversee the implementation of the site monitoring approach to ensure trials are monitored based on SOPs, relevant regulations.


    Regulatory and / or Organisational Requirements


    Ensures all tasks are carried out in accordance with respective applicable Standard Operating Procedures (SOPs), processes and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with values. 

    Job Complexity

    Works within a complex Good Clinical Practice (GCP) and regulatory environment and on global clinical trials with multi-disciplinary, international teams and with various internal and external stakeholders including vendors and investigational sites.

    Represents the company for the function at internal and external meetings, e.g. with investigational sites or regulatory agencies/inspectors. Failure can have impact on the reputation of company with stakeholders and regulatory agencies. More than one assignment in parallel requires balancing conflicting priorities. Is involved in design and implementation of new innovative methods as working group member 

    Interfaces*

    Functional leadership role within a clinical trial with no direct report. Liaises and partners with multi-disciplinary, international teams and both internal (i.e. functions inside and outside of Medicine) and external stakeholders (including vendors, investigators and site teams, clinic/hospital representatives, regulatory authorities/inspectors) in the context of clinical trials. 

    Job Expertise

    Proven track-record of solid site monitoring experience covering at a minimum 4 years of CRA experience and all stages of clinical trials (i.e. site selection, initiation, conduct and close-out). trial management experience is a plus


    In-depth knowledge of International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP) and understanding of legal/regulatory environment as it pertains to major regulatory authorities and relevant directives/regulations.


    Solid project management and internal/external communication skills.


    Job Impact

    Functionally responsible for the site monitoring approach, processes and oversight for global clinical trials for products in clinical development or post approval to ensure that robust and quality data is collected that support registration of products. Site monitoring has a significant impact on the budget and regulatory assessment of a clinical trial. 


    Accountabilities * Related performance indicators

    Trial Preparation:
    Deliver site monitoring approach for the trial when assigned:

    • Develop Trial Level Monitoring Manual and provide related input into trial plans, processes (e.g. trial risk assessment, Trial ISF/TMF, IMP management, Supplier selection such as central imaging or laboratory) and documentation (e.g. input into CTP, IQRMP, IC and develop SFQ and other relevant site logs/ forms such as source data status report, etc.).

    Deliver site monitoring oversight plan for the trial:

    • Develop Site monitoring oversight plan and provide


    Completeness and quality of the assigned documents.

    related input into trial level supplier oversight plan. in a trial, when assigned Ensure appropriate training: 

    • Provide input into trial training plan and develop and deliver trial-specific training for Clinical Research Associates (CRAs). 
    Support streamlined data collection: 
    • Provide input into eCRF 
    • Support development of checklists/templates (as appropriate) and support IRT set-up (input into IRT requirements/set-up and conduct UAT) 
    • Participate as appropriate in trial team meetings, International/regional investigator meetings and Drug supply meetings 
    Facilitate communication with Clinical Trial Managers (CTMs) and CRAs.

    Trial Conduct:

    Oversee site monitoring activities in the trial:
    •Issue management / oversight on trial level: review and assess site issues, escalate to CTL as appropriate, prepare for trial oversight/MQR meetings and follow up on further actions with countries when applicable
    •Pre-identify important protocol deviations from site issues/deviations for CTL(and TSTAT)or TCM to take final decision.
    •Pro-active risk mitigation: perform regular risk indicator review as applicable and determine and follow up on required actions
    •Maintain site monitoring approach for the trial and update Trial Level Monitoring Manual, site monitoring oversight plan and other core trial documents such as ISF templates etc. as required
    •Conduct process and site quality performance monitoring and checkpoint calls or visits with the CRAs in a trial according to the site monitoring oversight plan, implement follow-up actions and escalation as required

    Facilitate communication and training related to site monitoring in the trial:
    •Communication with CTMs, CRAs, perform re-training etc.
    •Participate, prepare input and (co-)lead trial oversight meetings

    A final Trial Level Monitoring Manual prior to the first Site Initiation Visit in a trial when assigned

    A final site monitoring oversight plan prior to the first Site Initiation Visit 

    Timely update of the trial level monitoring manual when assigned, site monitoring oversight plan and other core documents.

    No critical findings in audits and inspections regarding completeness and quality of the assigned documents.

    Conducts work in a professional manner as evidenced by feedback from internal and external stakeholders. 

    Trial Close-out:

    Coordinate DBL planning with Trial Team and countries.

    Support compilation and review of the quality section for the clinical trial report for site monitoring activities.

    Facilitate communication:
    •With CTMs and CRAs

    Adherence to all timelines.

    Conducts work in a professional manner as evidenced by feedback from internal and external stakeholders. 

    Liaison with relevant functions within COJ to oversee document translation process within COJ, including but not limited to:
    •delivery of document translation by external vendor
    •Arrange review of translated documents and ensure quality.

    Timeliness of document translation. Quality of translated document. 

    Act as a trial monitor to perform monitoring activities if assigned per SOPs, applicable international and Japanese regulations / guidelines 

    Management and Relationship Responsibilities:

    Adhere to international, local and internal requirements in the planning, conduct and reporting of clinical trials. 

    Conducts work in a professional manner as evidenced by feedback from internal and external stakeholders. 

    Support the development of company relationships with opinion leaders and set up good working relationship with investigational site staff, internal staff, Vendors. 

    Proactive behavior. 

    Participate in working groups related to site monitoring.

    Management and Relationship Responsibilities:

    Adhere to international, local and internal requirements in the planning, conduct and reporting of clinical trials. 

    as a member of COJ, participate and contribute to different initiatives within COJ to achieve its vision, and priorities

    Expires on 13 Apr 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

    Minimum Education/Degree Requirements*

    University degree in life sciences or related field OR

    equivalent professional education may be acceptable if complemented by solid work experience as CRA.


    Required Capabilities (Skills, Experience, Competencies)*

    Agility:

    Coordination and oversight; setting priorities, processing and analyzing data and information

    Achievement and performance driven


    Accountability:

    Deciding, problem solving, independence

    Communication, cultural sensitivity, clear and transparent, internal and external focus, collaboration and team work


    Intrapreneurship:

    Digital solutions for trial management Driven to learn and grow


    Solid knowledge in and experience with site monitoring processes and expertise with relevant tools and systems (e.g. Electronic Data Capture (EDC), Site Management System (SMS)).


    Capable of performing site monitoring activities (CRA responsibility) at any stage of a clinical trial if required


    computer skills:

    Excel, Word, Outlook, Powerpoint, Internet and Boehringer Ingelheim systems

    Language:

    fluent in verbal, and written communication English 

  • 25 Feb 2019

    Health Outcomes Scientist (担当課長/専門課長/専門部長)

    Japan

    Permanent Position
    アメリカ系製薬企業 - 1876年に創業、140年を超える歴史がある。米国インディアナ州インディアナポリスに本社を置く、革新を追求する医薬品のリーディング・カンパニーです。世界各国の自社研究施設や外部の優れた科学的研究機関との提携による最新の研究成果を用いて、各治療領域で最高レベルの豊富なポートフォリオの医薬品を開発しています。世界120ヵ国以上で事業を展開しています。

    Job Description

    【職務内容/Job Responsibilities】
    ・Environmental Awareness and Strategy development
     -Be aware of most current health outcomes methodologies and applications
     -Develop HO research strategy to maintain access or pricing; deliver collaborative work products that align with overall brand strategy
    ・Study Development, Information Dissemination
     -Develop specific research programs over the life cycle of product
     -Define and shape research with key partners; apply technical expertise to conduct scientific health outcomes research 
     -Manage timely deliveries with business partners 
     -Communicate health outcomes information internally, and to scientific community and customers in appropriate scientific venues

    Expires on 13 Apr 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

    【必須経験/Required Experience (mandatory for hiring)】
    ■Prior experience in designing, conducting research and disseminating research results. 


    【望ましい経験/Desirable Experience】
    ■Pharmaceutical industry work experience


    【必須応募スキル・知識・資格/Essential skills, Knowledge and license (mandatory for hiring)】
    ■Advanced degree (PhD, MD, PharmD or MPH, Master’s degree in relevant discipline eg. epidemiology, health administration, health services, medicine, phamacoeconomics, statistics) or relevant prior training in these areas.
    ■Strong business English and Japanese communication skill.



    【望ましいスキル・知識・資格/Desirable skills, Knowledge and license】
    ■Market access, pricing, government affairs, health care systems in major countries


    【必須ビヘイビア/Essential Behavior(mandatory for hiring)】
    ■Ability to work successfully in a team-oriented or cross-functional environment with strong communication and interpersonal skills
    ■Global thinking, customer focus and solution orientated 

    【このポジションの魅力/The attractiveness of this job】
    ■ Able to be involved in diverse research methodologies
    ■ Able to be involved in overall life cycle of product from development to commercialization
    ■ Able to be trained, on global perspectives, in technical, business and other development areas
    ■ Diverse career development opportunities

  • 18 Feb 2019

    Site Activation Lead

    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 Summary
    Our Study Start-up Services are building for a bright future. Site activation is currently one of the most challenging aspects within the project lifecycle. Due to the fast nature of the business Study Start Up works within, we’re looking to develop our team to reach for new frontiers of performance and quality. You will be responsible for the coordination and lead of the country Study Start Up teams for multi-country studies; Driving the teams’ efficiency and adherence to study procedures and timelines; Establishing regulatory requirements and site contracts to ensure a smooth start-up process; Liaising and coordinating with Project Manager to facilitate consistent communication for start up. The Site Activation Lead be the team motivator for the Study Start Up team.

    Expires on 13 Apr 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

    Roles and Responsibilities

    •Travel (approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings.

    •Attend BID Defence meetings, as directed, to provide strategic study start up advice.

    •Attend Kick Off Meetings, for all assigned studies, to provide strategic input into the study start up discussions

    •Draft CA, EC and contract execution plan (including other local study start up requirements) and monitor the execution of the plan including any revised timelines.

    •Work with key parties to draft mitigation plans against contractual targets for key milestones.

    •Responsible for the inclusion of the Study Start Up Plan in to the Project Management Plan to be shared and agreed with the sponsor.

    •Fully accountable for the implementation of the Study Start Up Plan for all assigned studies .

    •Responsible for the harmonization of processes and procedures during start up across the region and appropriate training of the team members.

    • In collaboration with the Project Managers identify and present interdependencies to the project team and track key deliverables against responsible parties, driving forward strategies to prevent “Road Block” situations.

    •Plan, coordinate and drive all study start up activities as defined by the SOW from site identification list to IP release to achieve the agreed/contracted deliverables and timelines in all countries including

    •Accountable for the preparation and coordination of submissions to regulatory, ethics and other bodies in all countries for assigned studies.

    •Accountable for the development, finalisation and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs).

    •Accountable for providing sponsor advice on the content of drug labels including the review and translations of drug labels where costed for.

    •Accountable for ensuring all submission packages receive an independent quality review prior to submission.

    •Accountable for co-ordinating the timely negotiation of contracts and budgets with sites.

    •Accountable for the co-ordination of translations for documents required for submission for assigned studies.

    •Accountable for timely and accurate data entry of all study start up activities in the appropriate clinical trial management system.

    •Accountable for the timely follow-up for queries made by CA/EC on assigned studies.

    •Accountable for the collection of critical documents required for IP Release on assigned studies.

    •Where necessary, ensure implementation of an escalation plan as agreed in the study communication plan.

    •Work directly with PM and ICG legal group to establish a defined Clinical Trial Agreement (CTA) process from fallback text to site execution of the CTA. The sponsor may directly be involved in this process or the ICG legal team may discuss directly with the sponsor.

    •Ensure adherence to the SOW and the site activation budget as per the costing model.

    •Manage study resources as appropriate per SOW at any phase of the study. Identify out of scope activities and negotiate changes required to SOW and budget as necessary with the PM.

    •Responsible for establishing format of the standard status report with PM to ensure the sponsor and study management needs are achieved, providing the reports as agreed, to the study management team. •Provide regular communication to the project manager identifying issues/targets/resolutions. Innovate, motivate and empower the site activation team to deliver on the timelines milestones with clear. measurable objectives. Inform site activation Regional/Country Management teams to mitigate risk as appropriate.


    Experience and Qualification

    · Preferably with a degree in Life Sciences, you will have previous submissions/dossier experience within clinical studies for either a CRO or Pharmaceutical company.

    · Minimum of 7 Years of experience in a clinical trial lead environment, preferably with Study Start Up Lead experience

    · Knowledge and experience in the clinical study start up requirements and activities for all assigned countries (or the ability to find this out for new countries)

    · Good organizational skills and the ability to manage multiple tasks

    · Meticulous attention to detail

    · Good written and verbal communication skills. Proficient in English and language required for country assignments

    · Highly developed problem solving skills

    · Strong people management and effective communication skills

    · Strong project management skills

    · Customer service focused

    · Competent computer skills 


    給与は前職考慮の上で決定いたします

  • 18 Feb 2019

    Senior Clinical Trial Manager

    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

    Overview of the role
    •Primary point of contact for Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients

    •Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects

    •Contribute to the development and maintenance of cross functional project management plans

    •Responsible for risk mitigation strategies, associated action plan and issue resolution

    •Responsible for managing the Clinical Operations project team, including ensuring all necessary project training is provided to assigned staff

    •Provide direction and support to the Clinical Operations study team

    •Collaborate with Business Development (BD) to ensure timely completion of change orders

    •Track Clinical Operations project deliverables using appropriate tools

    Expires on 13 Apr 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

    Role Requirements
    •A satisfactory progression of monitoring experience, along with previous experience in leadership and/or management activities

    •Previous working experience within the clinical trial management field.

    •Business level in written and spoken English.

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