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台北 02-2912-6104 轉 2
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台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
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Site Activation Partner II

  • 全職

ROLE SUMMARY

The Site Activation Partner is responsible for leading and supporting operational activities, from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.

Responsibility span within a country or multi-country depending on the geographical region and business needs

Clinical Trial Site Activation

Take the Lead, initiate and coordinates activities related to compilation of high-quality IRB/EC package and ensure timely submission to approval and other committees as per country requirements
Support investigators sites with local IRB workflow from preparation, submission through approval
Collaborate with in country regulatory group, and other stakeholders and provide related/applicable site documents as applicable
Coordinate the timely communication, documentation and responses between Pfizer and Ethics committees/sites to bring clinical study to approval
Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation
Prepare, validate and submit essential documents for internal sponsor regulatory group approval within required timelines
Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
Collaborate with the Study Team on the development and readiness of sites eISF when utilized
Support & implement activities in Shared Investigator Platform to align with Pfizer strategy
Coordinate translation of documents that are within scope with the preferred translation vendors
Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness
Clinical Trials Conduct

Ensure continuation of IRB/Ethic’s and other committees activities Post SIV, and related submission, notifications, reapprovals etc..
Post site activation, maintain the coordination of activities of essential documents updates and management with the investigator’s sites through the life cycle of a study
Maintain TMF and systems during study conduct
Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections
Additional Responsibilities:

Be a Subject Matter Expert on one or more system and/or process
Represent the SAP role on global initiatives

工作條件

  • 接受身份: 上班族
  • 工作經歷: 二年以上
  • 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
  • 其它條件: BASIC QUALIFICATIONS

    School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred
    Minimum 4 years relevant experience in Clinical Trials environment, Ethics environment and clinical site activation.
    Experience working in the pharmaceutical industry or CRO in a similar role
    Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, Global and local country regulations
    Deep understanding of the Site Activation requirements and processes within the country
    Must be fluent in Local language and in English. Multilingual capability is an asset
    Effective verbal and written communication skills relating to colleagues and associates both inside and outside of the organization
    Good technical skills and ability to learn and use multiple systems e.g CTMS, Network portals, SIP etc..
    Experience working in a global environment
    Experience in working in more than 1 country is an asset

    PHYSICAL/MENTAL REQUIREMENTS

    Ability to work under pressure to meet deadlines
    Understand the quality expectations and emphasis on right first time.
    Attention to detail evident in a disciplined approach
    Proven ability to work independently and also as a team member
    Ability to organize tasks, time and priorities, ability to multi-task
    Able to manage a high volume of, complex studies and sites
    Flexible and adapt to off working hours in a global environment (when applicable)

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:2021-09-15

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
新鮮人0%
1~3年0%
3~5年0%
5~10年100%
10年以上0%
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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