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1.Maintain the LMS e-solution system and support learning management across CRO Business Units and Functions.
維護LMS電子解決方案系統(tǒng)并支持CRO業(yè)務(wù)部門和職能部門的學習管理。
2.Conceptualize such GCP/GVP/GCLP relevant training, including development of content and evaluation of technical needs for deployment. Develop trainings as requested by and aligned with Business Functions and Process Owners; while adhering to the CRO learning management strategy to ensure the content works properly in learning solution.
概念化類似GCP/GVP/GCLP的相關(guān)培訓(xùn)，包括制定內(nèi)容和評估部署的技術(shù)需求。根據(jù)業(yè)務(wù)職能部門和流程負責人的要求開展培訓(xùn)，同時堅持CRO學習管理策略，確保內(nèi)容在學習解決方案中正常運行。
3.Maintain and continuously learn new methods of content development and to be up-to-date with the changing technology for assigned learning solutions.
維護并持續(xù)學習內(nèi)容開發(fā)的新方法，并與所分配的學習解決方案不斷變化的技術(shù)保持同步。
4.Provide support, consultation, and expertise on specific learning solutions.
為特定的學習解決方案提供支持、咨詢和專業(yè)知識。
5.Support key procedural documents development and process optimization in collaboration with functional Process Owner and SMEs.
與職能部門流程負責人和SME合作，支持關(guān)鍵規(guī)程文件的制定和流程優(yōu)化。
6.Support audit program establishment for the clinical trials.
支持臨床試驗稽查程序的建立。
7.Conduct audits of clinical trial sites, labs, computerized systems, vendors, protocols, and study reports and reports all audit observations to clinical sites, functional leadership team and clients, if applicable.
對臨床試驗研究中心、實驗室、計算機系統(tǒng)、供應(yīng)商、方案和研究報告進行稽查，并將所有稽查結(jié)果報告給臨床研究中心、職能領(lǐng)導(dǎo)團隊和客戶（如適用）。
8.Conduct system and process audits as required, e.g. Pharmacovigilance, data management, and safety reporting, etc.
根據(jù)需要進行系統(tǒng)和流程稽查，例如藥物警戒、數(shù)據(jù)管理和安全性報告等。
9.Support Computerized System Validation.
支持計算機化系統(tǒng)驗證。
10.Support the Client Audits.
支持客戶審計。
11.Support inspection Readiness state, local regulatory and health authority inspections as necessary.
必要時支持檢查地方監(jiān)管部門和衛(wèi)生當局檢查前的準備就緒狀態(tài)。
任職要求：
1.A Bachelor/Master of Science degree in Medicine, Pharmacy, Biology or relevant areas from an accredited college or university
具有醫(yī)學、藥學、生物學或相關(guān)領(lǐng)域?qū)W士/碩士學位。
2.A minimum of 2-3 years of progressively responsible experience within Clinical Development with at least taking 1 year QC/QA/QMS role.
至少2-3年臨床試驗相關(guān)工作經(jīng)驗，1年以上的QC/QA/QMS崗位經(jīng)驗。
3.Language skill: Excellent English speaking and writing skill is highly preferred.
語言技能：優(yōu)異的英語口語和書寫能力。