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求人掲載はこちら

  1. 日本語を使って働きたい人のための求人サイト
  2. 東京 で仕事を探す
  3. Clinical Operation Manager

Clinical Operation Manager

1000 〜 1400 万円

  • RGFタレントソリューションズ株式会社
  • 勤務地: 東京
  • 日本語レベル:流暢に話せるレベル │実務経験:未分類
  • 掲載終了
掲載期間:2019/11/14~2020/05/12

仕事概要

職種 専門職(コンサルタント、金融、不動産、専門サービス)/専門サービス(医療、福祉、教育、インストラクター)
業種 医療/ その他医療
雇用形態 未分類
ポジションレベル その他
募集人数 1名
希望入社時期 -
必須語学力

日本語 (流暢に話せるレベル)

英語 (ビジネスレベル)

活かせる語学 -
勤務時間 その他
福利厚生・休暇
ビザ取得支援 -
外国人従業員 -

仕事詳細

Company Overview
Global Pharma Maker

Job Description
•Accountable for all activities of site related study execution of assigned studies / Monitors involving start¬up, execution, and close¬out. Accountable for the on¬time and within budget study execution of assigned projects, including but not limiting to country and site feasibility.
•Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. Provide local regulatory and legal requirement expertise.
•Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies. May monitor regulatory reforms and industry trends within country / district, and provide impact analysis of significant changes affecting conduct of Clinical studies.
•Ensure audit and inspection readiness of assigned sites. Advise on pre¬audit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation.
•Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions.
•Responsible for the acquisition and retention, performance management, and growth and development of talent. May be responsible for being the country point of contact for CROs for an assigned study / studies. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.
•If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally. Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
•If assigned; Independently serve as key point of contact in country/district for one or more studies with higher level complexity. Update Impact/Tesla with country¬level information: Country¬level planning timelines, LSR assignments, etc.
•If assigned; Global Representative for single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
•If assigned; Accountable for resource management and deliverables of the assigned Remote Data Review (RDR) team. Collaborate with key stakeholders to ensure appropriate study specific training and assignment of assigned staff to studies. Responsible for the direct/functional management, as applicable, of the assigned Remote Monitors including hiring, onboarding, training, task assignment, mentorship, performance management, and growth and development.

Requirements
•Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred
•Site Monitoring Experience: Minimum 3 years.
•Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
•Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.
•Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment, with experience leading(within country) projects with competing deadlines; Experience across multiple Therapeutic Areas and Study Phases.
•Drives continuous improvement and simplicity in process and approach and enhances agility.
•Demonstrated business ethics and integrity.

面接について

連絡先

日本東京 地図



担当者名:

Clinical Operation Manager

RGFタレントソリューションズ株式会社

1000 〜 1400 万円

掲載終了

会社概要

RGFタレントソリューションズ株式会社 Clinical Operation Manager RGFタレントソリューションズ株式会社 Clinical Operation Manager

RGFタレントソリューションズ株式会社

人材、教育、コンサル、専門サービス /人材紹介、求人広告

RGF Professional Recruitment Japanは、日本最大規模の人材総合サービスカンパニー リクルートの海外展開ブランドにおける人材紹介部門の日本拠点です。日本国内でビジネスを展開する外資系企業並びにグローバル企業様を中心に、幅広いレベルのバイリンガル人材をご紹介しています。リクルートブランドとアジアの主要都市を網羅するRGFのネットワークを活かし、転職を希望される方、クライアント企業様双方にとって最適なサービスをご提供いたします。



RGF Professional Recruitment Japanの事業領域

RGF Professional Recruitment Japanはジュニアレベルからマネジメントレベルを中心に、すべての業種、職種の案件を取り扱っています。また、8,000,000を超える業界屈指の人材データベースから、大手外資系企業、グローバル企業に対して業界トップレベルの人材をご紹介することが可能です。

RGFプロフェッショナルリクルートメントジャパン
東京都品川区大崎2-1-1 ThinkPark tower 6階
(+81)3-6422-4400

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