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Data Management Lead II / データマネジメントリードII 在宅勤務可

Job ID 72002BR Tokyo, Tokyo, Japan
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ローバルチームをリードします。
  • 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:業務依頼から始まる要求確認
  • 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。
  • 品質、スケジュール、コストおよび顧客満足度を鑑みてプロジェクトをリードする。
  • データ品質の担保:データの問題を確認後、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
The Data Management Lead ll provides leadership and expertise in all aspects of Data Management. Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management’s single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness, financial management and quality.
The Data Management Lead ll works with minimal guidance from their Line Manager and/or Subject Matter Experts. DMLs may act as a mentor for ADMLs or other DML peers.
May act as Project Leader for projects involving only Global Data Operations services.

· 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
· Ability to travel as required
· Written and oral fluency in English

Qualifications

<必要業務経験>
  • 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

<求める人物像>
  • 交渉力(海外含む社内外の関係者)
  • グローバルチームと良好な関係を築ける
  • 問題解決力
· Strong experience in clinical research industry
· Proven record of leading project and program teams
· Good understanding and application of Parexel 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 Parexel SOPs and study specific procedures
· Awareness of SDTM/CDISC/CDASH standards
· 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

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