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)

Parexel International Corporation

Tokyo, Tokyo, Japa

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。 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 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.

· 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



· 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

2022-07-28 00:05:23

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