【正文】 ood team leadership skills Effective mentoring and training skills Excellent customer service skills Effective presentation skills Ability to manage peting priorities Strong software and puter skills, including MS Office applications Ability to establish and maintain effective working relationships with coworkers, managers and clients.Job title:Manager, Clinical Operations (China Beijing) DescriptionQuintiles pioneered the idea of helping pharma panies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational megatrials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outes faster.If that is your passion, we have a place for you.Job Responsibilities: Responsible to lead and manage the project team on regional or global studies Responsible for designing and overseeing the implementation of project specific procedures to ensure that the study goals are met Participate in clinical operations quality or process initiatives.Qualifications Degree in Science, with a major in Pharmacy, Biological / Life Sciences or Nursing from a recognized tertiary institution At least 7 years of experience working on clinical trials with 3 years experience in a leadership capacity. Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines Strong leadership skills Excellent organizational and problem solving skills Effective time management skills and ability to manage peting priorities Strong written and verbal munication skills Able to travel when required臨床實驗助理Job Responsibilities:Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintainingclinical systems that track site pliance and performance within project timelines.Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and pleteness.Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.Act as a central contact for the clinical team for designated project munications, correspondence and associated documentation.Provide administrative support to team members with clinical trial execution.Requirements:Awareness of knowledge of applicable clinical research regulatory requirements。 .,Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.Knowledge of applicable protocol requirements as provided in pany training.Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.Strong written and verbal munication skills including good mand of English languageAttention to detail and accuracy in work.Diploma or bachelor degree。or equivalent bination of education, training and experience CRASkills? Strong puter and internet skills including knowledge of MSOffice products such as Excel,Word? Strong regulatory knowledge including GCP? Excellent interpersonal, verbal and written munication skills? Sound problem solving skills? Ability to successfully work in a (‘virtual’) team environment? Sound presentation skills? Consultative skills? Client focused approach to work with the ability to interact professionally within a clientorganization? Ability to prioritize multiple tasks and achieve project timelines? Able to take initiative and work independently? Sense of urgency in pleting assigned tasks? Able to travel a minimum of 65% on average? Holds a driving license where required? Effective time management in order to meet daily metrics or team objectives? Shows mitment to and performs consistently high quality workEducation? Educated to degree level (biological science, pharmacy or other healthrelated disciplinepreferred), equivalent nursing qualification or other equivalent experienceLanguage Skills? Competent in written and oral English.Minimum Work Experience? Previous work experience (. CR Assistant, nursing, laboratory, data management) would beadvisable藥品安全經(jīng)理崗位職責(zé)：建立藥物安全工作的SOP體系1）建立與藥物安全有關(guān)的不良事件收集、員工和研究者培訓(xùn)、嚴(yán)重不良事件報告、定期不良事件更新報告、臨床方案和報告審閱、說明書審閱、文檔管理等相關(guān)SOP體系。 2）進(jìn)行年度SOP回顧，必要時進(jìn)行更新管理和培訓(xùn)1）對藥物安全專員進(jìn)行工作指導(dǎo)、檢查、培訓(xùn)、輔導(dǎo)和業(yè)務(wù)管理；2）根據(jù)需要對公司相關(guān)部門員工、研究者和CRO公司CRA進(jìn)行相關(guān)SOP培訓(xùn)，并記錄培訓(xùn)結(jié)果；3）與公司相關(guān)部門協(xié)調(diào)建立建全不良事件收集渠道；4）制定ACN藥物安全工作的發(fā)展規(guī)劃和年度計劃；審閱臨床研究方案、ICF/CRF、定期安全更新報告、臨床報告和說明書1）了解國內(nèi)外藥品臨床開發(fā)的進(jìn)展及相關(guān)資料。2）參與臨床試驗方案的討論，并給出有關(guān)藥物安全性方面的意見和建議；3）審閱臨床試驗方案（包括PMS）、ICF和CRF，給出合理的意見和建議，并簽字確認(rèn)；4）審閱并簽發(fā)藥物安全專員準(zhǔn)備的定期安全更新報告5）審閱臨床試驗報告和說明書的安全性內(nèi)容或信息，并給出合理的意見或修改建議；臨床試驗過程中不良事件收集和嚴(yán)重不良事件報告1）根據(jù)CRA（CRO公司）提供的嚴(yán)重不良事件報告表準(zhǔn)備英文報告，并在規(guī)定時限內(nèi)向API PV報告。2）對嚴(yán)重不良事件進(jìn)行跟蹤，并及時向API PV報告；3）對于ＡＣＮ發(fā)起的臨床研究，DSO應(yīng)將方案中有關(guān)藥品安全性的內(nèi)容以英文報告給API PV，　在取得臨床研究報告后，將報告中藥物安全性部部分的內(nèi)容以英文報告給API PV.4）對于由研究者發(fā)起并得到ACN支持的研究，督促研究者及時向DSO報告研究過程中的不良事件，DSO在規(guī)定的時間內(nèi)向API PV提交ＡＥ報告；5）在臨床試驗過程中向SFDA, 試驗基地及倫理委員會報告SUSAR Case。6）與臨床開發(fā)部門和CRO公司進(jìn)行良好的溝通以取得支持；其他1）協(xié)助注冊人員準(zhǔn)備多中心臨床試驗的風(fēng)險控制計劃；2）與API PV部門進(jìn)行有效的溝通與交流；3）接受API PV或監(jiān)理管機(jī)構(gòu)的審計4）定期接受有關(guān)藥物安全的培訓(xùn)，了解有關(guān)藥物安全的最新動態(tài)和知識；5）完成部門經(jīng)理交辦的其他任務(wù)工作要求：知識技能? 藥理學(xué)、或臨床醫(yī)學(xué)相關(guān)專業(yè)學(xué)士以上學(xué)位。 ? 與臨床有關(guān)的高等知識(病理生理學(xué)、診斷、內(nèi)科學(xué)、臨床藥理學(xué)等)。? 優(yōu)秀的領(lǐng)導(dǎo)和溝通協(xié)調(diào)能力? 計劃能力，分析和解決問題能力。? 良好的計算機(jī)、人際關(guān)系技能。? 能夠清晰、簡潔、有效地通過電話和書面進(jìn)行溝通；? 英語口語和書寫流利。 工作經(jīng)驗? 5年及以上藥物安全相關(guān)工作經(jīng)驗和管理經(jīng)驗。? 跨國制藥公司工作經(jīng)歷；? 對藥品安全有關(guān)法規(guī)和指南有正確的理解。? 與藥品警戒領(lǐng)域的專家能夠進(jìn)行良好的溝通和聯(lián)絡(luò)。