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台中 04-3700-6104
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Site Activation Partner I

  • 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. Ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.

ROLE RESPONSIBILITIES

Clinical Trial Site Activation

Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation
Prepare, validate, and submit regulatory documents such as completed Investigator Package, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study and other committees as per country requirements
Coordinate the timely communication, documentation and responses between Pfizer and Ethics committees to bring clinical study to approval (country dependent)
Collaborate 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
Clinical Trials Conduct

Post site activation, initiate and coordinate activities and essential documents management and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals and other activities required during study conduct
Ensure maintenance of IRB/Ethics and other committees’ activities as applicable
Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review
Accurately update and maintain clinical trial systems
Systems & Tools

Ability to use and learn systems, and to use independently, such as:

Microsoft Suite
Clinical Trial Management Systems (CTMS)
Electronic Trial Master File
Shared Investigator Platform
Ethics and Governing Bodies Portals and platforms (as needed)

BASIC QUALIFICATIONS & REQUIREMENTS

School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred
Minimum 2 years relevant experience in clinical site management.
Experience working in the pharmaceutical industry/or CRO in study site activation is an asset
Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
Must be fluent in Local language and in English. Multilanguage capability is an asset
For individuals based in Canada: Bilingualism (French, English) is an asset
Effective verbal and written communication skills
Understand the quality expectations and emphasis on right first time.
Ability to work independently and as a team member
Ability to organize tasks, time and priorities, ability to multi-task
Flexible and adapt to off working hours in a global environment (when applicable)

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 & REQUIREMENTS

    School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred
    Minimum 2 years relevant experience in clinical site management.
    Experience working in the pharmaceutical industry/or CRO in study site activation is an asset
    Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
    Must be fluent in Local language and in English. Multilanguage capability is an asset
    For individuals based in Canada: Bilingualism (French, English) is an asset
    Effective verbal and written communication skills
    Understand the quality expectations and emphasis on right first time.
    Ability to work independently and as a team member
    Ability to organize tasks, time and priorities, ability to multi-task
    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50%
3~5年0%
5~10年50%
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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