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Project Manager ＊Global環境で語学力を活かせます＊
年収：800万 ～ 1000万
採用企業案件
ICONクリニカルリサーチ合同会社
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- 会社規模501-5000人
- CRO
| 部署・役職名 | Project Manager ＊Global環境で語学力を活かせます＊ |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
This position is primarily responsible for managing all Data Monitoring Committee (DMC) and/or endpoint adjudication processes for a clinical trial. ICON Independent Data Monitoring Committee and Endpoint Adjudication (IDEA) Group The ICON Pharma Solutions IDEA group manages DMC and Adjudication committees that independently review clinical trial data in an effort to reduce bias and increase validity and scientific merit of trials. [Job Description] • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance. • As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. •Travel (approximately 35%) domestic and/or international. • Manages project in a timely manner in adherence with ICON's SOP's, ICH, GCP and appropriate regulation and liaise with other departments as necessary. • Delivers projects in accordance with the contract, timelines and study budget • Identifies out of scope activities and initiates budget change orders and contract amendments • Attends and presents at Investigator Meetings, Client Kick-Off Meetings, and other client meetings • Facilitates the electronic endpoint adjudication system for the endpoint adjudication project • Ensures all necessary study specific training is provided to study team to improve performance and knowledge. Provides coaching I mentoring as necessary. • Develops and maintains all trial documentation (i.e. Charter, Procedure Manual, Site Manual, Adjudication Forms, Communication Plan, System Requirement Specifications, Data Transfer Specifications, and Committee Training Manual) • Performs user acceptance testing of electronic endpoint adjudication system • Performs data reconciliation • Serves as the primary study contact for client and internal and external study teams. • Leads internal and external study team meetings. • Leads internal DMC and endpoint adjudication processing team. • Develops and monitors DMC and endpoint adjudication processing workflows to maintain efficiency • Prepares meeting agenda and facilitates the completion and distribution of meeting minutes • Facilitates the development of project reports. Generates and distributes project reports to the study team. • Coordinates DMC and Endpoint Adjudication • Committee members and data review/adjudication process • Conducts project/system specific training to committee members • Implements Quality Control measures for adjudication process and adjudication outcomes as necessary • Performs project finance reporting activities • Provides feedback to senior management on project status, metrics, client satisfaction and staffing issues. • Participates in bid defense and new proposal review activities as necessary • Participates in internal, client, and regulatory audits • Other duties as assigned |
| 応募資格 |
【必須（MUST）】 • Business level of English including listening, speaking, and writing• Background of healthcare industry • Basic knowledge of clinical database |
| アピールポイント | 外資系企業 女性管理職実績あり 年間休日120日以上 産休・育休取得実績あり 従業員数1000人以上 シェアトップクラス 海外事業 完全土日休み フレックスタイム |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/06/06 |
| 求人番号 | 3178738 |
採用企業情報
- ICONクリニカルリサーチ合同会社
-
- 会社規模501-5000人
- CRO
-
会社概要
【代表者】小川 淳
【従業員数】1,000名 ※2024年4月現在
【本社所在地】大阪府大阪市中央区久太郎町4-1-3
【その他事業所】東京オフィス（東京都港区虎ノ門4-3-9）
【事業内容】
1．医薬品、医療機器、再生医療等製品、ワクチン等にかかる臨床開発、 市販直後調査、製造販売後調査、臨床研究等の受託事業
2．労働者派遣事業
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です