お仕事情報

お仕事情報

Clinical Trial Oversight Manager:SS-4133MY

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

世界最大の独立バイオテクノロジー企業と、内資系研究開発型グローバル製薬企業との合弁会社

求人コード SS-4133MY
募集職種 Clinical Trial Oversight Manager
職務内容 ・Primary point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues
・Provides support of clinical study execution
・Provides Global Study Operations - Site Management (GSO-SM) functional area expertise
and actively collaborates in a dynamic cross-functional environment
・Oversight of the site contracting, budgeting and payment process
・Line Manager of Site Contracts and Budget Associates (SCBAs)
応募要件 <Basic Qualifications>
・Doctorate degree OR
・Master’s degree OR
・BA/BS/BSc or qualified nurse (RN)
・Work experience in life sciences or medically related field, including biopharmaceutical
clinical research experience (clinical research obtained working on clinical trials in a biotech,
pharmaceutical or CRO company, or other relevant clinical setting)

<Preferred Qualifications>
・Broad work experience working in life sciences or medically related field, including clinical site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company
・Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical
industry
・Experience in a project leadership role
・Experience working with or for Functional Service Provider or Contract Research
Organizations
・Supervisory Experience
・Knowledge of or work experience with a biopharmaceutical R&D compliance, auditing or QC

<Knowledge>
・Familiarity with advanced concepts of clinical research
・Extensive knowledge of ICH/GCP regulations and guidelines
・Strong knowledge of clinical trial operations
・Understanding of Functional Service Provider operational model
・Computer and system operation skills
・Relevant therapeutic area education and training
・Detailed understanding of customer service
・Demonstrated ability to anticipate and resolve problems

<Competencies>
・Demonstrated ability to work independently with minimal supervision
・Ability to work effectively in a team/matrix environment on multiple projects
・Excellence in relationship building
・Ability to lead and influence in a positive manner
・Leadership
・Strong interpersonal skills
・Excellent organizational and planning skills
・Excellent oral and written communication
・Language: Business English fluency
・Attention to quality and detail
・Ability to identify and resolve problems
・Flexibility
・Ability to write and present clearly using scientific and clinical issues terminology
・Attention to quality planning and execution
・Ability for critical thinking and thinking out of the box
勤務地 東京
年収 1000万円~1300万円
最終学歴 理系大卒
推奨される資格要件 PhD、理系
その他

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