パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Data Management Lead I / データマネジメントリード I（在宅勤務・東京・大阪・神戸）
応募 求人ID 80201BR ロケーション 東京都, 東京都 仕事内容
データマネジメントリードは、臨床開発データマネジメントの専門的知識と経験、卓越した交渉力を発揮し、プロジェクト達成に向けてグ関係部署と協業しグローバルチームをリードします。
· Strong ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
· Strong negotiation skills and ability to influence in order to achieve mutually beneficial results
· Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
· Learning ability and knowledge sharing approach; swift understanding of technologies and new processes
· A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments
· Proficient presentation skills
· Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust
· Commitment to first time quality, including a methodical and accurate approach to work activities
· Time management and prioritization skills, in order to meet objectives and timelines
· Proven problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses
· Ownership and accountability for Key Accountabilities in Job Description·
・データマネジメント業務 5年以上
・プロジェクトやプログラム（データマネジメント・プログラミング）チームをリードした経験
・ビジネスレベルの英語・日本語（日本国外アジア地域在住の方も応募可能）
· Strong experience in clinical research industry with Data Management role for 5 years
· Proven record of leading project and program teams
· Good understanding and application of project tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.
· Good understanding of Clinical Study Team roles outside of Data Management
· Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and SOPs and study specific procedures
· Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products
応募あとで応募 - 戦略的計画立案：データマネジメント・プログラミングに関するニーズや問題点をクライアントと協議のもと計画立案をする
- クライアントとの折衝：業務依頼の要求確認
- 臨床試験の進捗を考慮したデータマネジメント・プログラミングのタイムラインとマイルストーンの作成と実施に向けて関係部署との調整
- 国内・海外のリソースを駆使し、データマネジメント・プログラミングを遂行する
- データ品質の担保：データで問題を確認後、ソリューションを提供・解決しデータ品質を確保する
- 関連法規やSOP、契約に基づいた手順等を遵守し、タイムラインまでにデータを解析に提供する
- データ入手、チェック、クエリ発行、データ変更などステータス管理
· Strong ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
· Strong negotiation skills and ability to influence in order to achieve mutually beneficial results
· Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
· Learning ability and knowledge sharing approach; swift understanding of technologies and new processes
· A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments
· Proficient presentation skills
· Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust
· Commitment to first time quality, including a methodical and accurate approach to work activities
· Time management and prioritization skills, in order to meet objectives and timelines
· Proven problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses
· Ownership and accountability for Key Accountabilities in Job Description·
Qualifications
・医薬品開発、臨床試験に関する十分な知識・データマネジメント業務 5年以上
・プロジェクトやプログラム（データマネジメント・プログラミング）チームをリードした経験
・ビジネスレベルの英語・日本語（日本国外アジア地域在住の方も応募可能）
· Strong experience in clinical research industry with Data Management role for 5 years
· Proven record of leading project and program teams
· Good understanding and application of project tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.
· Good understanding of Clinical Study Team roles outside of Data Management
· Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and SOPs and study specific procedures
· Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products
