メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

CRAの採用・育成・配置を通じて質の高い試験実施を支援します。
治験実施施設の選定から開始、被験者登録、データ収集、問題解決までの監督を行い、GCPや規制に準拠したモニタリングの品質管理を担います。
施設スタッフとの良好な関係構築に注力し、試験目標達成をサポート。
チームのパフォーマンス評価や教育、予算管理も担当し、国内外の規制対応やPMDA査察支援も行います。

■休日：完全週休二日制, 年末年始

Qualification Required:
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Education Required:
Bachelors degree or higher in a scientific or healthcare discipline preferred
A minimum of 5-6+ years of relevant clinical operations experience.

Other Qualifications:    
Associate CRM: 1-3 years of people management or project management in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field
CRM: 3 years or above of people management and project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field
Senior CRM: 5 years or above of people management and project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field
CRM/Senior CRM: Solid understanding of career development and performance management activities
Documented training, knowledge and application of current Regulations, GCP and ICH guidelines in clinical trials required
Evidence of team leadership capabilities
Therapeutic or medical knowledge preferred
Exhibits a strong understanding of methodologies and approaches
Understanding of all aspects of monitoring and trial execution
Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.
Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities, local/National Health Authorities regulations and BeiGene standards
Strong written and verbal communicate effectively with site personnel, country and global associates
Computer skills including proficiency in use of Microsoft office,
Excellent organization skill and management of competing priorities         

■職種未経験者：不可