• Deliver best value and high quality service
• Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
• Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
• Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.
• Use efficient programming techniques to produce derived datasets, tables, figures and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures and data listings
• Check own work in an ongoing way to ensure first-time quality.
• Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
• Proactively participate in quality improvement initiatives.
• Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required
• Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
• Provide relevant training and mentorship to staff and project teams as appropriate.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.
• Proficiency in SAS.
• Knowledge of the programming and reporting process
• Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
• Demonstrate ability to learn new systems and function in an evolving technical environment
• Attention to detail
WHY Parexel
– 百瑞精鼎是台灣外商CRO中,您最佳的職涯發展選擇
• 國際化的工作環境: Parexel 百瑞精鼎 為全球前三大以及全台最大的CRO公司。 台灣為亞太區核心據點,將近500名員工分布在60多個部門,提供多元廣闊的職涯可能性。
• 歷史悠久,豐富的臨床產業經驗與資源: 與世界級藥廠與生技公司合作,在全球銷售前200名的藥品中,Parexel參與99% 的藥品臨床試驗。 • 台灣快速成長,亞太區為重要據點: Parexel 百瑞精鼎台灣2018年員工成長快速高達13%,公司超過1/3的員工位於亞太區。
• 組織營運穩定,職位安全性高: 公司優良的制度提供了穩定的職涯發展環境,近六成主管於Parexel任職八年以上。 • 招募新鮮人與完善的職能訓練: 每年提供眾多實習、工作機會、優良的到職訓練給在學生/應屆畢業生。
• 內部職涯發展: 2019年招募職位中超過三成為員工內轉及升遷,台灣身為亞太區域中心擁有60多個部門,提供您多種職涯可能性。
• 升遷管道通暢: 高績效為公司核心文化,依表現升遷優秀員工,不限年齡或在職期間等門檻限制。
• 高度彈性的工作型態: 通勤族:不罰錢不記點,上班再也不用趕公車、超速了! 成家族:自由調配工作時間,可配合家庭生活需要
• 多元族群,拓展視野:
Parexel Taiwan員工來自全球各地,包含美國、德國、法國、日本、南韓、中國、加拿大、肯亞、馬來西亞等。
公司內實現跨國員工密切合作,眾多以英語及第二外語溝通的機會。
Improving the lives of patients every day With Heart.
經營理念
近年獲獎榮耀 -
2020 CRO Leadership Awards in 6 categories (Capabilities, Compatibility, Expertise, Quality, Phase IV, and Reliability)
- 2020 彈性工作百大企業Top 100 Remote Work (by FlexJobs)
- 2020 亞太區最佳數位化供應鏈獎 (by Biologistics World Asia Conference)
- 2018 MERCER中國最佳健康雇主
- 2017 Training Top 125 Winner (by Training Magazine)
- 2017 Forbes America's Best Employers - 2016 衛生福利部國民健康署台灣健康職場認證
- 2016 CRO Leadership Award in Capabilities and Expertise