
Site Optimization Officer (SSU)

職位描述
Major responsibilities
? Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents.
? Assist in coordination of clinical studies from site selection through site activation. That involves but not limited to
? Conduct SQV in selected sites;
? Take EC application and get EC approval from confirmed sites;
? Negotiate, finalize and get final signing of the clinical study agreement and related amendments from confirmed sites;
? Assist to get HGR application required documents from confirmed sites.
? Assist local study team to prepare site initiation visit in site.
? Actively participate in local Study Delivery Team meetings and work cross functionally with Clinical Trial Support Team in China SM&M.
? Activate study sites in compliance with Procedural Documents.
? Share information (metrics) on study site progress towards activation within local Study Delivery Team and China SM&M leadership as required.
? Drive delivery of regulatory documents at the sites. Proactively identify delays in start-up activities and the risks to the activation plan.
? Update IMPACT and other systems with data from centres as per required per Site Optimization Team (SOT) process.
? Ensure regulatory binders are provided for study site start up and/or delivered as per SOT process and agreement with Local Study Delivery Team.
? Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
? Ensure compliance with company’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
? Ensure completeness of the Study Master File for study start-up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva).
? Ensure that all start up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
? Contribute to the production of study start up documents, ensuring template and version compliance.
? Create and/or import clinical-regulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the Authoring Guide for Regulatory Documents to support publishing in ANGEL.
? Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems.
? Regular communication with key/mega site and influence the trial delivery in hospital level.
Additional Responsibilities May Include
? Contribute to process improvements, knowledge transfer and best practice sharing.
? Actively share applicable information that may be relevant to other functions.
Requirement:
? University degree in related discipline, preferably in life science, or equivalent qualification.
? Fluent knowledge of spoken and written English.
? In total 2-4 years working experience. Previous experience as CRA is a must, previous experience as SSU is a plus.
? Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
? Good knowledge of relevant local regulations.
? Basic understanding of the drug development process.
? Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
? Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
? Ability to travel nationally as required.
企業(yè)簡(jiǎn)介
科文斯,全球性的合同研究組織(CRO)Covance Inc.是全球服務(wù)最全面的藥物研發(fā)公司。
我們致力于推動(dòng)醫(yī)療保健事業(yè)發(fā)展并實(shí)現(xiàn)Solutions Made Real?,通過向制藥公司和生物科技公司提供高質(zhì)量的非臨床、臨床前試驗(yàn)、臨床和商業(yè)化服務(wù),幫助減少藥物研發(fā)的時(shí)間和成本。憑借豐富的經(jīng)驗(yàn)與深厚知識(shí),我們具備獨(dú)特的優(yōu)勢(shì),能為客戶合作伙伴提供不僅僅局限于測(cè)試的獨(dú)到見解。
我們還向化學(xué)品、農(nóng)用化學(xué)品和食品行業(yè)提供實(shí)驗(yàn)室測(cè)試服務(wù),同時(shí)也是毒理學(xué)分析服務(wù)、中心實(shí)驗(yàn)室服務(wù)、藥物篩選服務(wù)的市場(chǎng)領(lǐng)導(dǎo)者,以及III期臨床試驗(yàn)管理服務(wù)的全球頂級(jí)提供商。
科文斯官網(wǎng): https://www.covance.com/
職位發(fā)布企業(yè)
科文斯醫(yī)藥研發(fā)(北京)有限公司上海分公司
企業(yè)性質(zhì):外資企業(yè)
企業(yè)規(guī)模:5000-10000人
成立年份:2006
企業(yè)網(wǎng)址:www.covance.com
企業(yè)地址:上海市普陀區(qū)嵐皋路555號(hào)602-606室
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職位發(fā)布日期: 2019-04-25

