■ 職務内容 / Job Description Job purpose In line with the business (ONC/CVRM/R&I/V&I/Medical) divisions’ objectives, the role holder will • Maximize the business value of global/local IT initiatives in ONC/CVRM/R&I/V&I/Medical business domain, by ensuring effective alignment
業務内容 メディカルモニタリング:日本に割り当てられたプロジェクトのメディカルアドバイザーとして以下の役割を担う ・プロトコルの明確化、組入れ基準の決定、患者さんの安全性・適格性の問題を含むプロトコル関連の問題について、プロジェクトメンバーや治験実施医療機関に対し医学的アドバイスを行う ・プロトコル、治験薬概要書、症例報告書の医学的レビューを行う ・プロジェクトチームに対し、疾患領域や適応症に関するトレーニングを提供する ・インヴェスティゲーター・ミーティングに参加する ・有害事象のレビューを行う ・ファーマコビジランス部門と協力して、重篤な有害事象のレビューを行う ・ファーマコビジランス部門と協力し、またはその代理として、累積/類似症例の分析をサポートする ・有害事象コーディングの医学的レビューを行う ・総括報告書とナラティブのレビューを行う ・キックオフミーティング、チームミーティング、クライアントミーティングに参加する ・就業時間以外にプロトコル関連する緊急問題が生じた場合は、所定のルールに従ってタイムリーに対応する 候補者要件 ・日本における医師免許 ・4年以上の臨床経験(研修期間含む) ・血液内科または消化器内科の臨床経験(研修期間含む) ・語学力 日本語:あらゆるコミュニケーションの場面におけるビジネスレベルの能力 英語:読む・書くについてビジネスレベルの能力。および、聞く・話すについて日常会話が可能であり、就業後に能力を向上する意欲があること ・5年以上の臨床経験(研修期間含む) ・血液内科または消化器内科の専門医認定 ・語学力 英語:あらゆるコミュニケーションの場面におけるビジネスレベルの能力。 勤務時間 原則フルタイム(7.5hour/day フレックスタイム適用) パート・時短・曜日限定勤務などは応相談 勤務地 ・自宅/リモートベース(研修や会議のため、入社後2か月程度の間は、週に1-3回のペースでオフィス(東京都品川区/大阪市淀川区)勤務要) IQVIA is a leading global provider
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