JOB INFORMATION
求人情報

求人番号 81485-050

製薬・医療機器業界

外資系 メディカル

クリニカル・リサーチ・アソシエイト

  • 年収
    非公開
  • 勤務地
    東京都
  • 英語力
    中級

米国に本社を置き、100年を超える歴史を持つグローバルな研究開発型のバイオ医薬品企業です。

職務内容
Purpose :
To enable **** emergence as a world class R&D organization, the position anticipates and proactively solves studyュrelated clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of SMM deliverables involving startュup, execution, and closeュout of studies.
Responsibilities :
・Monitors activities conducted by clinical investigative sites as they relate to **** clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, **** Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
・Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and **** Standard Operating Procedures (SOPs) and business processes.
・Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.
・Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and followュup for all safety events by site personnel.
・Ensures safety and protection of study subjects through compliance with the study monitoring plan, **** SOPs, ICH Guidelines, and applicable regulations.
・Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
・Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.
・Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal**** requests to assist in the placement of planned clinical studies with qualified investigators.
応募条件
・Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
・Minimum of 1 year of clinicallyュrelated experience, of which a period of 6 months is preferable in clinical research monitoring. Experience in onュsite monitoring of investigational drug or device trials is required
・Current inュdepth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
・Current inュdepth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
・Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.
・Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.
・Demonstrated business ethics and integrity.
無料オンライン登録

厳選求人詳細

  • 外資系 メディカル

    PMSモニター

    ・製造販売後調査実施における施設対応 ・医療機関への調査説明及び依頼 ・契約手続...

    この求人の詳細を見る
  • 外資系 メディカル

    Product Manager(クリアレンズ)

    - マーケティング部に所属し、クリアレンズをご担当いただきます - 日本法人では...

    この求人の詳細を見る
  • 外資系 メディカル

    セールスアソシエイトマネージャー

    【Role Overview】 セールスの活動計画を立案・実行し、所属組織の方針...

    この求人の詳細を見る
  • 無料登録

求人検索

  • 管理部門の転職情報
  • ISSコンサルティング採用情報
  • オンライン登録

転職のご相談、求人応募・お問い合わせには、
まず無料登録をお願いします。

無料オンライン登録

SNS

企業インタビューやセミナー
業界転職情報をお届け!

Arrow