求職服務專線
台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
意見回饋
廠商求才專線
台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

Clinical Trial Oversight Manager

  • 全職

Application directly received from Amgen Career site will be reviewed first: https://careers.amgen.com/job/13495243/clinical-trial-oversight-manager-taipei-tw/

KEY RESPONSIBILITIES

• Performs sponsor oversight activities of Functional Service Provider (FSP), including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials.
• Collaborates closely with FSP Line Manager to ensure appropriate level of their staff oversight is deployed.
• Supports FSP staff onboarding and training
• Supervises staff involved in local site contracting and budget management, insurance and payment process as a line manager
• Point of escalation for all stakeholders to support resolution of issues e.g. quality, staff turnover and performance concerns
• Works with FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out
• Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
• Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution
• Organizes and leads regular meetings with FSP and any other country-level project review meetings, if applicable.
• Involved in local and global site management and cross-functional stakeholder collaboration
• Actively participates in role forums including local and global functional and cross-functional initiatives

工作條件

  • 接受身份: 上班族
  • 工作經歷: 八年以上
  • 學歷要求: 大學以上
  • 語文條件: 不拘
  • 其它條件: QUALIFICATIONS

    • Bachelor’s Degree or the equivalent (BSc is preferred)
    • Broad work experience working in life sciences or medically related field, including clinical trial site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company
    • Experience in people management or project management role at regional level in South East Asia and Taiwan in clinical trials
    • Experience working with or for FSP or Contract Research Organizations
    • Experience of contract and budget negotiation and management

    KNOWLEDGE

    • Familiarity with advanced concepts of clinical research
    • Extensive knowledge of ICH/GCP regulations and guidelines, and local regulations in SE Asia and Taiwan
    • Strong knowledge of clinical trial operations
    • Understanding of FSP operational model
    • Relevant therapeutic area education and training

    COMPETENCIES

    • Leadership skills, ability to lead and influence in a positive manner
    • Demonstrated ability to work independently with minimal supervision
    • Ability to work effectively in a team/matrix environment on multiple projects
    • Excellence in relationship building
    • Strong interpersonal skills
    • Excellent organizational and planning skills
    • Excellent oral and written communication in English and Mandarin
    • 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

福利制度

法定項目

其他福利

1. 年底薪12個月,另有績效獎金及通訊補助
2. 年休假15天,按年資每年增加一天;生日假、志工假、暑假歡樂星期五(提早下班)及全年30天給薪病假及其他法定休假及國定假日
3. 依法享勞保、健保及勞工退休金
4. 員工團保(含配偶、及未成年子女)
5. 員工健康檢查、健康促進補助、流感疫苗施打補助
6. 員工在職訓練
7. 開放的辦公室工作環境及設備,有升降式辦公桌並設有育嬰室
8. 員工協助方案
9. 福委會: 員工旅遊津貼、台灣安進成立周年禮金、尾牙聚餐及抽獎 …等

以上為正職員工福利,約聘人員相關福利請另洽人資。

更新日期:2021-10-12

應徵方式

  • 職務聯絡人: 陳小姐
  • 聯絡E-Mail: (請利用104履歷表應徵此工作) 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽

應徵分析

兩週內0-5人應徵
經歷分佈
新鮮人0%
1~3年0%
3~5年50%
5~10年0%
10年以上50%
學歷分佈
碩士及以上50%
大學50%
專科0%
高中0%
高中以下0%

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