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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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Lead Data Manager

  • 全職

Senior Lead Data Manager
Location: Taiwan

Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.

Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.

Position overview:

As an Senior Lead Data Manager, you will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it.

Key responsibilities will include:

• Services rendered will adhere to applicable sponsor SOPs, Wis, policies, local regulatory requirements, etc.
• Provides data management support, oversight and/or accountability for one or more clinical trials.
• May Take a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).
• With the trial customer, CRO and other functional partners:
o Gathers content and integration requirements for eCRF and other data collection tools.
o Establishes conventions and quality expectations for clinical data.
o Establishes expectations for dataset content and structure.
o Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.
• Performs trial level oversight controls as described in the oversight plan, QC process, and work instructions with minimal DML direction.
• Reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
• Ensures real-time inspection readiness of all Data Management deliverables for the trial Participate in Regulatory Agency and internal audits as necessary.
• Helps plan and track content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan, and archival. Ensures deliverables are on time.
• Participates in the assigned clinical working group(s) to ensure that Data Management and TA trial needs and deliverables are met. Helps Identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.
• Presents and trains at investigator and monitor meetings if needed

工作條件

  • 接受身份: 上班族
  • 工作經歷: 五年以上
  • 學歷要求: 大學以上
  • 語文條件: 英文 -- 聽 /中等、說 /中等、讀 /精通、寫 /精通
  • 其它條件: An experienced project leader, a strong communicator, and solution-oriented.

    To ensure success within this role, the following are required:

    • Data management experience preferred
    • Experience working on clinical trials
    • Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional.
    • Project management skills
    • Vendor management skills
    • Highly organized with excellent written and verbal communication
    • Ability to interpret clinical trial data and present trends to the clinical trial team on data
    • A BA or BSc degree in a health or science-related discipline
    • At least 5 years above DM experience in clinical field (CRO/Pharma)
    • Fluency in English

福利制度

法定項目

其他福利

員工是保瑞爾生技股份有限公司最重要的資產與最具競爭力的優勢,為了吸引最優秀的人才及落實完整的員工照顧,我們提供卓越的福利與薪酬制度,包括優於業界的優渥薪資、嚴謹的全球化教育訓練、平衡的工作與生活、完整的保險與精密的健康檢查,並提供海外出差的週全保險,最高規格的SOS海外救援服務,提供員工心理諮商服務,給予員工身心靈的全方位照顧。
獎 金 福 利: 年節獎金
休 假 福 利: 週休二日、特休假15天起,每年增加2天、全年12天給薪病假,18天半薪病假
保 險 福 利: 勞保、健保、員工及團保(包括壽險、意外醫療、癌症醫療、職災險;部分包括配偶及子女);勞退金6%提撥、年度健康檢查、免費流感疫苗注射
訓 練 發 展: 員工線上或實體在職教育訓練、人才培訓計劃
◎全方位的保險保障規劃:除依法為每位員工投保勞工保險、全民健康保險;也規劃了團體綜合保險,包括壽險、意外險、醫療險、癌症險、重大疾病險等,除提供員工個人保障外,針對員工之配偶及其子女,亦提供團體醫療險及癌症險等保障,我們同時提供團體保險保障予員工及其家人,體現公司照顧員工的心意
其他福利:寬敞明亮的工作環境,公司提供免費研磨咖啡、牛奶、零食餐點

更新日期:2021-10-21

應徵方式

  • 職務聯絡人: TangSandy
  • 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

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