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Project Manager (~SrDir) / Oncology BU 、CNSBU、 St…

【Essential Functions】  ・Project Administration Acts as a primary liaison between the Company and …

求人会社名:非公開

メンバー
1000万円~2000万円

募集要項

  • こだわり条件

    設立50年以上 語学(英語)を生かす 年間休日120日以上 土日祝日休み

  • 仕事内容

    【Essential Functions】
     ・Project Administration Acts as a primary liaison between the Company and the Customer to ensure study launch conduct and closeout according to the Customer’s and the Company's contractual agreement. Coordinates project organization implementation and management activities between all Company operations and the client. Manages the executed contract and financial aspects of assigned projects including reviewing study budgets and expenses. Oversees and tracks site payment issues as required. Alerts Finance on the need for Customer invoicing. Oversees the regulatory document collection and submission process. Ensures project documentation including Trial Master Files are complete and audit ready. Assists in the negotiation and contracting process with outside vendors (labs printers etc). May perform or oversee site feasibility assessments. Reviews protocol Case Report Forms and edits specifications for consistency within each document cross checking these documents against each other. Develops and maintains project plans for the study in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WI). Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status resourcing and tracking reports and functional area plan to appropriate team members and senior management. Performs ongoing review of project financial status of studies. Alerts senior management to potential issues and ensures necessary corrective action is taken.
     ・Communication Independently prepares and presents study material at client meetings and communicates outcomes to project team at review meetings. Attends clinical monitoring staff meetings project team meetings clinical committees and clinical training sessions according to the project communication project management monitoring and/or training plans.
     ・Business Development Develops strong relationships with cur…

  • 職種分類

    素材・化学・食品・メディカル系技術者 > 医療・医薬・メディカル系技術者 > 研究・開発(医療・医薬・メディカル)

  • 業種分類

    医薬・バイオ

  • 応募条件

    BA/BS in the life sciences nursing degree or equivalent combination of education and experience. Moderate clinical research experience in a contract research organization (CRO) pharmaceutical or biotechnology company. Previous technical and managerial experience in conducting multi national and/or local clinical trials in a hospital setting pharmaceutical company or CRO. Some time must have been spent actively managing clinical research projects across functional areas. Thorough knowledge of regulatory requirements drug development and clinical monitoring procedures. Demonstrated proficiency with ICH/GCP guidelines. Keen insight independent judgment
    and tactful discretion. Strong presentation documentation and interpersonal skills as well as a team oriented approach. Proficient computer skills in Word Excel PowerPoint email and Internet. Basic computer skills using MS Project. Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.

  • 年収

    1000万円~2000万円
    1000万円 - 2000万円

  • ポジション

    メンバー

  • 雇用形態

    正社員

  • 勤務地

    東京都 / 大阪府

  • 勤務時間

    09:00 ~ 18:00

  • 休日・休暇

    【有給休暇】11
    【休日】完全週休二日制


    祝日
    GW
    夏季休暇
    年末年始
    ※年次有給休暇は入社月により換算されます(4月入社なら11日、5月入社10日付与)
    ※夏季休暇は、仕事の都合に合わせて有給を取得いただけます。

  • 福利厚生

    【通勤手当】全額支給
    【社会保険】健康保険
    厚生年金
    雇用保険
    労災保険

求人会社情報

  • 事業概要

    求人紹介時にご案内致します。

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    【Essential Functions】  ・Project Administration Acts as a primary liaison between the Company and …

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