- 目錄
第1篇 管理研究專員崗位職責(zé)任職要求
管理研究專員崗位職責(zé)
工作職責(zé)
根據(jù)公司政策和sop的要求，維護(hù)臨床運營中心培訓(xùn)系統(tǒng)及流程。
定期和相關(guān)崗位的直線經(jīng)理溝通討論，確定和更新各崗位的培訓(xùn)計劃。
根據(jù)培訓(xùn)計劃建立相關(guān)的培訓(xùn)資料，并及時跟進(jìn)行業(yè)進(jìn)展以及法律法規(guī)的發(fā)展，結(jié)合公司業(yè)務(wù)發(fā)展需求和崗位設(shè)置等，定期回顧和更新相關(guān)培訓(xùn)材料。確保培訓(xùn)質(zhì)量。
向沒有行業(yè)經(jīng)驗的公司員工提供臨床研究的基礎(chǔ)培訓(xùn)和基礎(chǔ)工作技能培訓(xùn)。
和各臨床研究項目負(fù)責(zé)人一起，按照質(zhì)量管理計劃的要求，完成所需的質(zhì)量管理工作。
將在質(zhì)量管理工作中發(fā)現(xiàn)的問題和相應(yīng)的建議組織成相應(yīng)的培訓(xùn)課程。
任職要求
臨床醫(yī)學(xué)、藥理學(xué)、護(hù)理學(xué)、衛(wèi)生護(hù)理或其他醫(yī)學(xué)專業(yè)。
豐富的臨床研究相關(guān)知識以及法律法規(guī)知識，熟悉臨床監(jiān)查的過程。二年以上臨床監(jiān)查工作經(jīng)驗或相同經(jīng)歷。
熟練的計算機技能。
優(yōu)秀的表達(dá)能力和書面溝通能力。能獨立工作，獨立思考，改進(jìn)流程。
管理研究專員崗位
第2篇 管理研究專員崗位職責(zé)
工作職責(zé):
? the irc associate provides primary operational support to various programs within medical affairs platform strategy (maps) group which including but not limited to investigator initiated research (iir), clinical research and collaboration (crc), compound transfer program (ctp), clinical data request (ctd), independent grants for learning & change (iglc) and publications programs.
? the major responsibilities including but not limited to: maintaining systems, share point sites and databases used for program management; receive, generate and distribute program related documents & report according corresponding pfizer sops and guidelines; process eligibility check, finance transactions and drug distribution as requested.
? the irc associate will work closely with program managers with necessary communication and coordination to ensure efficient program process and compliance.
任職資格:
? bachelor’s degree (ba, bs) required with preference for a focus in science, healthcare or related field.
? good written and oral english skills, japanese fluency highly desired.
? operational experience in clinical trial management, educational grants or healthcare industry (pharmaceuticals, life sciences, and medical).
? knowledge of it systems/software for database maintenance and document management.
? demonstrated effectiveness working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change and diversity.
? good understanding of multiple disciplines (e.g., healthcare compliance law, regulatory, drug supply, clinical study, medical affairs, medical educational grant, publication development, project and financial management) and organizations (e.g., pfizer country offices and regions)
? experience with various pfizer processes/systems/functions: mapp (fcpa), ariba sap reporting strongly preferred.
? developed customer service skills and team work spirit.
