Job Description

募集要項

【求人No NJB2352566】
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。

応募必要条件

職務経験	無し
キャリアレベル	中途経験者レベル
英語レベル	ビジネス会話レベル
日本語レベル	ネイティブ
最終学歴	大学卒： 学士号
現在のビザ	日本での就労許可が必要です

スキル・資格

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

勤務地

• 東京都 23区

労働条件

雇用形態

正社員

給与

1000万円 ~ 1400万円

勤務時間

09:00 ～ 18:00

休日・休暇

【有給休暇】有給休暇は入社時から付与されます 入社7ヶ月目には最低10日以上 【休日】完全週休二日制 年末年始 ・年末年始休暇…

業種

医薬品

職種

会社概要

会社の種類

外資系企業

Job Tags

Similar Jobs