臨床試験のデータ管理部門シニアアソシエイト job opportunity at Alcon.

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DateMore Than 30 Days Ago bot
Alcon 臨床試験のデータ管理部門シニアアソシエイト
Experience: General
Pattern: full-time
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degreeGeneral
loacation Tokyo, Japan, Japan
loacation Tokyo, Japan....Japan

＜職務の目的＞ 当局申請のため、臨床試験データ（データベース・症例一覧表・解析帳票）の品質を保証する  ＜職務内容＞ ・臨床試験のデータベース、統計解析帳票の品質管理 ・臨床試験のデータマネジメント、統計解析に関するPMDA書面調査対応用の各種申請資料の作成・整理 ・申請準備のための、プログラムを用いたデータチェックの実施、一覧表等の作成 ・CRO の業務管理 ・上記業務におけるグローバルチームとの業務連携   医療機器・医薬品に関する当局申請業務のための書面調査提出資料や社内資料の作成・整理業務を行って頂きます。開発関連部門と協働しながらの業務となります。対象となる臨床試験は弊社で計画・実施したもの、買収等により他社から引き継いだものの 2 種類あります。 申請プロジェクトの企画段階から業務に参加して頂き、スケジュールやコストなどについて部門の立場から助言、発信を行って頂きます。データベース、プログラミングに関する理解と技術、他部門に伝達するための柔軟なコミュニケーション能力が必要となります。 当面はプログラミング関連の業務が主なものですが、将来はクリニカルバイオメトリクス部を率いて活躍して頂ける人材を募集します。 ＜応募資格＞ 英語：会議用の資料作成とプレゼンができる程度 スキル：SAS、R、またはほかの言語（応相談）によるプログラミング経験（５年以上） 　　　　CDISC、EDC等の電子的成果物を扱うPMDAへの申請業務経験（５年以上） 　　　　電子的成果物に関するPMDAの規制・ガイドラインの知識    ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker

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