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

Country Trials Manager

  • 全職

ROLE SUMMARY

The Country Trials Manager is responsible for study startup deliverables for assigned studies at a country level that are of moderate to high complexity. For studies where there is more than one country trial manager assigned, may act as the Lead Country Trials Manager for the country or cluster of countries and coordinate all the country activities. The Country Trials Manager partners with the Study Start Up Project Manager, Study Manager, Site Intelligence Lead, Site Relationship Partner, Site Activation Partner, Contracts Lead, Regulatory Affairs, CRO representatives) and others as required. The Country Trials Manager provides leadership and country strategic planning and organization skills to ensure the delivery of operational Start up aspects of one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.
Accountable for the execution of:
• Country level implementation of Startup and Site Activation Plans
• Country level Recruitment Strategy
• Timely and quality EC/RA Submissions 
• Communication with internal stakeholders as listed above to ensure efficient and timely study startup delivery at a country level

工作條件

  • 接受身份: 上班族
  • 工作經歷: 七年以上
  • 學歷要求: 大學
  • 語文條件: 英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
    中文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 具備駕照: 普通小型車
  • 其它條件: Training and Education
    • A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc; a nursing diploma or associate degree in nursing may also be considered with extensive clinical trial experience.
    • Extensive operational clinical trial experience
    • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
    • English and region/country local language is required.


    PREFERRED QUALIFICATIONS

    Prior Experience
    • + 7 years of clinical research experience and/or study management/startup project manager experience
    • Demonstrated knowledge of site selection, site activation, site readiness interdependencies
    • Demonstrated knowledge of clinical trial methodology and the drug development process
    • Demonstrated experience leading cross functional teams
    • Demonstrated experience in Project Management and Quality Management
    • Demonstrated experience in a matrix management environment

    Skills and Technical Competencies
    • Expertise in the use of Site Activation tools
    • Detail oriented & possesses technical expertise
    • Ability to manage complex processes
    • Ability to manage in a matrix environment
    • Risk Identification & Mitigation
    • Strategic Planning, Analytical and Problem-Solving Skills
    • Critical Path Analysis
    • Excellent communication skills, both written and verbal
    • Ability to adapt to changing technologies and processes
    • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization 

    Behavioral Competencies
    • Seeks to develop an integrated view of key issues to shape decisions and strategy development and suggest ways to improve
    • Proactively manages change by identifying opportunities and coaching self and others through the change 
    • Demonstrated ability to introduce new ideas and implement them 
    • Effectively overcoms barriers encountered during the implementation of new processes and systems 
    • Builds effective relationships with customers and other stakeholders 
    • Works well across country boundaries, respecting communication and cultural differences in interpersonal relationships 
    • Acts as a mentor for other Country Trials Managers.

福利制度

1. 業務同仁獎勵辦法 / 績效獎金制度
2. 員工旅遊
3. 主管與業務同仁汽車提供辦法
4. 週休二日
5. 勞工保險
6. 國定假日及年假制度
7. 全民健康保險
8. 退休制度
9. 團體保險
10.同仁在職進修補助
11.年度健檢
12.員工子女獎學金
13.社團活動
14.中秋、端午、春節三節禮金

更新日期:2021-07-06

應徵方式

  • 職務聯絡人: HR
  • 聯絡E-Mail: 未填寫 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
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學歷分佈
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