- 目錄
崗位職責是什么
臨床數據崗位是醫(yī)療健康行業(yè)中至關重要的角色，主要負責收集、整理、分析和管理與臨床試驗相關的大量數據，以支持醫(yī)療研究、新藥開發(fā)和患者治療決策。
崗位職責要求
1. 具備扎實的醫(yī)學基礎知識，熟悉臨床試驗流程及法規(guī)。
2. 精通數據分析工具，如sas、r、python等，能處理大規(guī)模數據。
3. 嚴謹細心，確保數據準確無誤，遵守數據保護和隱私法規(guī)。
4. 良好的溝通協調能力，與研究團隊、醫(yī)療專家及監(jiān)管機構有效協作。
5. 掌握項目管理技巧，能在多任務環(huán)境下高效工作。
崗位職責描述
臨床數據專員的工作涉及多個環(huán)節(jié)，從設計數據收集方案，到實施數據錄入、清理和驗證，再到生成統計報告，每一個步驟都需要精確無誤。他們需要理解和解讀復雜的醫(yī)學文獻，確保臨床試驗數據的科學性和可靠性。此外，他們還需與跨學科團隊密切合作，解決數據問題，確保研究進度順利進行。
有哪些內容
1. 數據管理：制定數據標準，建立數據庫，進行數據錄入、校驗和管理。
2. 數據分析：運用統計學方法對數據進行深度分析，發(fā)現潛在模式和趨勢。
3. 報告撰寫：編寫詳細的臨床研究報告，呈現數據分析結果，供決策參考。
4. 項目協調：參與臨床試驗項目的規(guī)劃和執(zhí)行，確保數據質量和合規(guī)性。
5. 問題解決：針對數據異?；驙幾h，與研究團隊共同尋找解決方案。
6. 持續(xù)學習：關注醫(yī)療領域最新發(fā)展，提升數據分析技能，適應不斷變化的行業(yè)需求。
臨床數據崗位的工作是醫(yī)療創(chuàng)新的關鍵一環(huán)，通過精準的數據處理和分析，推動新療法的研發(fā)，改善患者預后，為醫(yī)療行業(yè)的進步貢獻力量。
臨床數據崗位職責范文
第1篇 臨床數據分析員崗位職責
臨床數據分析員 江蘇恩華藥業(yè)股份有限公司 江蘇恩華藥業(yè)股份有限公司,恩華藥業(yè),江蘇恩華藥業(yè),恩華 崗位職責:
1. 負責新藥臨床研究項目數據的統計與分析工作,收集整理臨床診療數據并進行挖掘分析;
2. 參與臨床試驗方案設計:試驗設計、樣本量計算、終點指標及其分析方法的選擇;
3. 獨立撰寫統計分析計劃;撰寫統計分析報告;
4. 負責和管理項目進度,以及程序相關的問題溝通;
5. 其他相關的統計分析。
任職要求:
1. 流行病與衛(wèi)生統計學、生物統計學、計算機、數學及相關專業(yè),碩士研究生;
2. 獨立完成過臨床數據收集、整理、挖掘分析工作;熟悉臨床試驗設計與統計分析流程,熟練使用sas、stata、spss,prismgraphpad等統計軟件和畫圖軟件;
3. 一年以上大型cro或藥廠臨床試驗sas程序員工作經驗者優(yōu)先。
4. cet6,英語聽說讀寫能力良好;
5. 熱愛生物醫(yī)學數據分析工作,邏輯思維強,具備優(yōu)秀的團隊合作能力和獨立解決問題的能力。
第2篇 臨床數據經理崗位職責
臨床數據經理 primary activities include, but are not limited to:
? all responsibilities of a clinical data manager.
? assume data management responsibilities for larger, more comple_ or higher priority protocols.
? may coordinate general ad-hoc sponsor data entry (sde) process for the protocol, discuss timelines, and provide data entry status to the clinical development scientist (cds).
? provide protocol specific training of sde process to cdm.
? triage, research, discuss and resolve the reports outputs provided by clinical development scientist (cds) and statisticians at a protocol level during in-life and database lock stages supported by the lcdm.
? supports the lcdm in the preparation, creation and review of data management tool specifications and tools
? participates in user acceptance testing (uat) of the clinical database repository under the direction of the lcdm.
? coordinates communications, global status tracking and issue resolution at study level with lead cdm (lcdm).
? responsible for the communication with clinical trial operations team regarding site level issues on protocol a basis on behalf of the lcdm.
? monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues and deliver status and resolution updates to lcdm.
? responsible for study level status assessment, reporting and communication with lcdm.
? complete trial level archiving activities under the direction of the lcdm including, but not limited to, filing of essential documentation.
? coordinate and mentor cdms and other scdms who work in his/ her protocol to ensure their compliance with sops, data management plans and data review plans.
? be assigned to special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as providing inputs to create or update sops, supporting documents and training materials as needed.
? may be required to support dmc process owner (po) models in the local dmc and/or in the global po networks.
? participate in cross functional technical or process improvement projects.
manual encoding lead
? perform all responsibilities of a manual encoder under the clinical data manager.
? ensure encoding accuracy and consistency across all protocols within a project.
? works closely with dmc manual encoders and data management trial manager (dmtm) to ensure all encoding tasks are completed prior to interim analysis, frozen files/ database locks.
? serves as subject matter e_pert (sme) for encoding documents and processes.
? responsible to review specified therapeutic area encoding as requested.
? coordinates with lcdm to create and review encoding specifications documents and performs user acceptance testing (uat) of coding application (s).
? responsible for encoding e_ternal partner data as applicable and consultant for contract research organization (cro) partners.
? runs encoding check reports in accordance with data review plans to identify encoding issues.
? raises questions with investigational site staff or dmc manual encoders and reviews responses and corresponding data corrections to confirm resolution.
? responsible for study level encoding status reporting and assessment, and communication with dmc clinical trial (ct) management during in-life data management activities and preparation for database lock.
requirements
education:
1. at least b.a. or b.s. degree, preferably in medicine, pharmacy, nursing, biological sciences, or health care related discipline.
knowledge and skills:
1. two years’ e_perience in clinical data management in pharmaceutical or health care clinical research environment is preferable.
2. self-motivated, e_cellent in work planning and time management.
3. fluent oral and written english skills.
4. good basic awareness of the clinical development process.
5. good basic awareness of clinical practice and grasp of medical terminology.
6. good sense and awareness of regulations and policies.
7. able to work under pressure and in a changing environment with fle_ibility.
8. good communication skills with the ability to communicate with both technical and business areas.
9. proven leadership skills, specifically the ability to coordinate the work of others and influence management on decision making. primary activities include, but are not limited to:
? all responsibilities of a clinical data manager.
? assume data management responsibilities for larger, more comple_ or higher priority protocols.
? may coordinate general ad-hoc sponsor data entry (sde) process for the protocol, discuss timelines, and provide data entry status to the clinical development scientist (cds).
? provide protocol specific training of sde process to cdm.
? triage, research, discuss and resolve the reports outputs provided by clinical development scientist (cds) and statisticians at a protocol level during in-life and database lock stages supported by the lcdm.
? supports the lcdm in the preparation, creation and review of data management tool specifications and tools
? participates in user acceptance testing (uat) of the clinical database repository under the direction of the lcdm.
? coordinates communications, global status tracking and issue resolution at study level with lead cdm (lcdm).
? responsible for the communication with clinical trial operations team regarding site level issues on protocol a basis on behalf of the lcdm.
? monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues and deliver status and resolution updates to lcdm.
? responsible for study level status assessment, reporting and communication with lcdm.
? complete trial level archiving activities under the direction of the lcdm including, but not limited to, filing of essential documentation.
? coordinate and mentor cdms and other scdms who work in his/ her protocol to ensure their compliance with sops, data management plans and data review plans.
? be assigned to special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as providing inputs to create or update sops, supporting documents and training materials as needed.
? may be required to support dmc process owner (po) models in the local dmc and/or in the global po networks.
? participate in cross functional technical or process improvement projects.
manual encoding lead
? perform all responsibilities of a manual encoder under the clinical data manager.
? ensure encoding accuracy and consistency across all protocols within a project.
? works closely with dmc manual encoders and data management trial manager (dmtm) to ensure all encoding tasks are completed prior to interim analysis, frozen files/ database locks.
? serves as subject matter e_pert (sme) for encoding documents and processes.
? responsible to review specified therapeutic area encoding as requested.
? coordinates with lcdm to create and review encoding specifications documents and performs user acceptance testing (uat) of coding application (s).
? responsible for encoding e_ternal partner data as applicable and consultant for contract research organization (cro) partners.
? runs encoding check reports in accordance with data review plans to identify encoding issues.
? raises questions with investigational site staff or dmc manual encoders and reviews responses and corresponding data corrections to confirm resolution.
? responsible for study level encoding status reporting and assessment, and communication with dmc clinical trial (ct) management during in-life data management activities and preparation for database lock.
requirements
education:
1. at least b.a. or b.s. degree, preferably in medicine, pharmacy, nursing, biological sciences, or health care related discipline.
knowledge and skills:
1. two years’ e_perience in clinical data management in pharmaceutical or health care clinical research environment is preferable.
2. self-motivated, e_cellent in work planning and time management.
3. fluent oral and written english skills.
4. good basic awareness of the clinical development process.
5. good basic awareness of clinical practice and grasp of medical terminology.
6. good sense and awareness of regulations and policies.
7. able to work under pressure and in a changing environment with fle_ibility.
8. good communication skills with the ability to communicate with both technical and business areas.
9. proven leadership skills, specifically the ability to coordinate the work of others and influence management on decision making.
第3篇 臨床數據崗位職責
醫(yī)學數據分析師 hitales 上海翼依信息技術有限公司,hitales,上海翼依,翼依,翼依科技,翼依 跟隨國內知醫(yī)療信息學副教授,參與醫(yī)療人工智能項目。
醫(yī)學數據分析專員
崗位職責
1、負責醫(yī)學相關臨床數據的整理、分析工作,參與醫(yī)學相關知識圖譜構建;
2、負責相關數據產品和治療領域的醫(yī)學文獻的檢索整理;
3、參與醫(yī)學大數據挖掘、分析工作;
4、參與公司醫(yī)療相關產品的需求收集、整理、分析;產品規(guī)劃、設計等工作;
5、參與公司醫(yī)學相關知識架構搭建及內容完善工作;
6、 負責查閱、收集國內外臨床試驗信息,掌握臨床試驗領域的發(fā)展趨勢;
7、協助開展相關領域的調研,為產品優(yōu)化提供科學依據。
任職資格:
1、臨床醫(yī)學、基礎醫(yī)學、公共衛(wèi)生、藥學等醫(yī)學相關專業(yè)本科畢業(yè);
2、2年以上醫(yī)學數據分析工作經驗
3、具有醫(yī)學臨床決策支持算法與系統構建經驗、有互聯網與人工智能相關工作經驗者優(yōu)先考慮;
4、良好的溝通能力和團隊合作精神;
5、為人謹慎,細致工作負責;
第4篇 臨床數據分析崗位職責
臨床數據分析 樂普 樂普(北京)醫(yī)療器械股份有限公司,樂普,樂普醫(yī)療,樂普醫(yī)療器械,樂普醫(yī)療集團,樂普移動醫(yī)療,北京樂普,樂普 職責描述:
1、熟悉臨床分析軟件;
2、在一定時間內收集、整理和核查(邏輯核查及醫(yī)學核查)臨床試驗數據;
3、確保臨床試驗數據的完整性、準確性和內部數據庫的一致性,使其符合報告至管理機構的質量標準;
4、與臨床監(jiān)察員和研究者就臨床報告管理工作進行密切溝通及協調。
任職要求:
1、醫(yī)學統計或相關專業(yè)本科及以上學歷;
2、使用過sas、spss、e_cel等統計分析工具;
3、良好的溝通能力及語言表達能力;
4、符合以下條件者優(yōu)先:有edc的使用經驗;有臨床數據管理經驗,有cra或crc工作經驗,有oracle database,sql使用和編程經驗者優(yōu)先;
第5篇 臨床數據分析師崗位職責
臨床數據分析師 上海森億醫(yī)療科技有限公司 上海森億醫(yī)療科技有限公司,森億智能,森億 職位描述:
1.根據項目需求,撰寫統計分析計劃書,獨立完成各類型的臨床研究的統計分析工作;
2.參與產品統計模塊的功能設計和測試;
3.根據產品、應用方向,對醫(yī)療大數據整體進行統計分析及數據挖掘;
4.對內部及外部進行統計培訓、項目介紹 。
職位要求:
1.衛(wèi)生統計、流行病學、統計學、應用統計等相關專業(yè)背景,碩士及以上學歷; 至少1年以上統計師、sas programmer、醫(yī)療行業(yè)數據分析等相關工作經驗;
2.從事臨床試驗統計分析者優(yōu)先,有醫(yī)療/健康數據分析及建模的經驗優(yōu)先;
3.熟悉醫(yī)學研究相關的統計方法;熟練掌握至少一門統計編程軟件:sas、r、python;
4.熟練使用sas或r繪制符合行業(yè)標準的統計表格和統計圖;
5.有醫(yī)藥企業(yè)或cro公司撰寫統計分析計劃書(sap)經驗優(yōu)先;
6.熟悉臨床研究思路、方案設計、樣本量計算等;
7.良好的學習能力、邏輯思維和語言表達能力。
第6篇 臨床數據助理崗位職責
臨床數據管理助理 佰榮泰華 北京佰榮泰華生物醫(yī)藥科技有限公司,佰榮泰華,佰榮泰華 崗位職責:
1、參與數據管理人工核查等工作;
2、配合數據管理員進行數據質疑等工作;
3、協助數據管理專員完成工作;
4、領導交辦的其他任務;
任職要求:
1、專科以上學歷;
2、工作細心踏實,責任心強;
3、能承擔重復的工作;
4、有發(fā)現錯誤的敏感度;
5、有團隊溝通和協調能力;
6、能熟練使用辦公軟件;
