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Job Overview
Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers

【主な業務内容】

・臨床試験の品質、タイムラインの管理

・リスクマネジメントプランのレビュー、実施

・プロジェクトメンバーとなるCRAやCRA LMなどとの社内の調整・進捗管理

・スポンサー企業側や他部門との調整、進捗管理（日本、及びグローバルで対応）

　・他国クリニカルリード等との協業

【必須要件】

・ Life sciences 関連の学士号

・CRO・製薬メーカー・医療機器メーカー・バイオベンチャーで、以下ご経験をお持ちの方

　・臨床開発の実務経験　4年以上　（CRA経験含む）

　・グローバルスタディの実務経験

　・臨床部門でのチームリーダー/スタディーマネージャーまたは同様のご経験

【付帯要件】

・英語力：Reading、Writing、Speaking、Listening　いずれもビジネスレベル以上

＊TOEIC650点以上を目安としていますがこれから勉強する意欲が高い方も歓迎

※Non-Onco phase1試験のご経験をお持ちの方（CRA経験を含む）も歓迎しております（１年以上のCRAリーダーなどのリード経験でも可）

Qualifications
• Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.;
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.;
• Problem solving - Strong problem solving skills.
• Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
• Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
• Organisation - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Prioritisation - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
• Quality - Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
• IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com