崗位職責(zé):
1. Responsible for ensuring the clinical data are reliable, integrated and accurate.
確保臨床試驗(yàn)數(shù)據(jù)可靠,完整和準(zhǔn)確。
2. Ensure data quality and consistency according to applicable regulatory requirements, SOP(s), processes and data standards.
依據(jù)相應(yīng)法規(guī),標(biāo)準(zhǔn)操作規(guī)程,流程和數(shù)據(jù)標(biāo)準(zhǔn),確保數(shù)據(jù)質(zhì)量和數(shù)據(jù)一致性。
3. Ensure all data management activities to be compliant with GCP, relevant regulatory requirements and SOP(s) of Pharmaron Clinical and/or Sponsor.
確保數(shù)據(jù)管理工作符合GCP,相應(yīng)法規(guī)及標(biāo)準(zhǔn)操作規(guī)程的要求。
4. Ensure following and applying CDISC or applicable standard through Clinical Trail.確保執(zhí)行CDISC或相適用的數(shù)據(jù)標(biāo)準(zhǔn)。
5. Ensure acknowledging, following and to be consistent with Pharmaron Clinical policies and procedures.
確保了解、遵守并符合康龍臨床政策制度和流程。
6. Hands-on data management responsibilities include but not limited to:
數(shù)據(jù)管理主要職責(zé)包括但不限于:
? Data Entry (applicable to Paper study only). 數(shù)據(jù)錄入(僅適用于紙質(zhì)項(xiàng)目)。
? CRF collections, maintenance and tracking (applicable to Paper study only).
病例報(bào)告表(CRF)的收集、整理及追蹤(僅適用于紙質(zhì)項(xiàng)目)。
? User acceptance testing for database.
用戶驗(yàn)收測(cè)試。
? Perform data cleaning activities including discrepancy management and manual review (review of data listings to verify quality and completeness of data).
數(shù)據(jù)清理包括質(zhì)疑的管理和人工審閱(查看數(shù)據(jù)列表確認(rèn)數(shù)據(jù)質(zhì)量及完整性)。
? Create data reports and listings per data review plan.
根據(jù)數(shù)據(jù)審閱計(jì)劃創(chuàng)建數(shù)據(jù)列表和數(shù)據(jù)報(bào)告。
? Reconcile the clinical database with external data.
臨床數(shù)據(jù)庫(kù)和外部數(shù)據(jù)的一致性核查。
? Reconcile the clinical database with the safety database.
臨床數(shù)據(jù)庫(kù)和安全數(shù)據(jù)庫(kù)的一致性核查。
? Local lab range management.
實(shí)驗(yàn)室正常值范圍的管理。
? Familiar with the structure, content and function of MedDRA、WHODrug or other medical coding dictionaries (if applicable).
熟悉MedDRA、WHODrug字典或其他醫(yī)學(xué)編碼字典的結(jié)構(gòu)、內(nèi)容與功能(如適用)。
? Perform coding of medical terms regularly following the dictionaries and frequency agreed in the coding plan (if applicable).
根據(jù)醫(yī)學(xué)編碼計(jì)劃商定的字典與頻率,定期進(jìn)行醫(yī)學(xué)術(shù)語的編碼工作(如適用)。
? Create the simple data management documentations under the supervision of senior members.
在高級(jí)數(shù)據(jù)管理人員指導(dǎo)下,撰寫簡(jiǎn)單的數(shù)據(jù)管理相關(guān)文檔。
7. Perform other duties as required.
視需要,執(zhí)行其他職責(zé)。
任職要求:
1. Demonstrated knowledge of GCP and other regulations' requirements of clinical trials. 了解GCP和其他臨床試驗(yàn)相關(guān)法規(guī)的要求。
2. Demonstrated knowledge of clinical trials. 了解臨床試驗(yàn)相關(guān)知識(shí)。
3. Good written and oral English to communication, and knowledge of medical terms. 能夠熟練運(yùn)用英語進(jìn)行書面和口頭的有效溝通并了解醫(yī)學(xué)術(shù)語。
4. Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.) 能夠熟練運(yùn)用Windows 系統(tǒng)及相關(guān)程序(如Word, Excel, PowerPoint, Project 等)。
5. Strong ability to analyze and learn new things. 具備很強(qiáng)的分析能力和學(xué)習(xí)新事物的能力。
6. High degree of enthusiasm and a strong sense of responsibility. 具備較高的積極性,較強(qiáng)的責(zé)任心
7. Adapt to work with highly-accurate, highly-attention of details, and strict quality control. 適應(yīng)高度精確性、非常關(guān)注細(xì)節(jié)及嚴(yán)格質(zhì)量控制的工作方式。
8.醫(yī)藥類、理工類相關(guān)專業(yè)本科及以上學(xué)位或?qū)W歷。