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Clinical Assay Lead-上海（Contract ）

2-2.8萬
  • 上海長寧區(qū)
  • 3-5年
  • 碩士
  • 全職
  • 招999人
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職位描述

藥理研究
崗位職責:
1、Serves as a member of the clinical study team and analytical subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development & review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
2、Functions as key point of contact with external & internal laboratories and supports (or leads, as appropriate) selection, qualification, performance evaluation, and periodic audits of CRO laboratories conducting clinical PK, PD and immunogenicity assays (as relevant to the role).
3、Supports the clinical trial conduct within scope of the Clinical Assay Group responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
4、Contributes to the development of Best Practices, processes, templates, and policies.
5、Maintains up-to-date knowledge of current and novel chromatographic separation/mass spectrometry based detection, ligand binding technologies & techniques or bioanalytical techniques commonly used for Biomarkers (as relevant to the role), global regulatory guidances & expectations, and industry best practices.
任職要求:
1、碩士學歷，醫(yī)藥專業(yè)；
2、要有大分子，小分析的經(jīng)驗；
3、英語聽說讀寫流利。
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工作地點

長寧區(qū)上海中山西路999號華聞國際大廈16樓

職位發(fā)布者

程紅/招聘

剛剛活躍
立即溝通
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泰格醫(yī)藥(股票代碼:300347.SZ/3347.HK)是行業(yè)領先的一體化生物醫(yī)藥研發(fā)服務平臺，為全球制藥和醫(yī)療器械行業(yè)提供跨越全周期的臨床研究創(chuàng)新解決方案。通過全面的服務體系和頂尖的質(zhì)量標準，我們助力生物醫(yī)藥產(chǎn)業(yè)提升研發(fā)效率、降低研發(fā)風險，確保研究項目高質(zhì)量交付，加速醫(yī)藥產(chǎn)品市場化進程，履行對行業(yè)和患者的承諾。同時，我們也通過覆蓋各領域的 100多家子公司，打造賦能全產(chǎn)業(yè)鏈的創(chuàng)新生態(tài)，推動醫(yī)療產(chǎn)業(yè)創(chuàng)新和發(fā)展。作為全球化的研發(fā)平臺，泰格醫(yī)藥在全球布局 180多個辦事處和分支機構(gòu)，擁有超過 9500人的專業(yè)團隊，覆蓋5大洲的 54個國家，致力于解決最具挑戰(zhàn)的全球健康問題，滿足患者的未盡醫(yī)療需求，創(chuàng)造社會價值，造福人類健康。更多詳情請登錄：http://tigermed.zhiye.com/或?qū)⒛暮啔v發(fā)送至：TA@tigermedgrp.com（請務必在郵件主題中注明：意向地區(qū)+意向崗位+姓名）
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