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      臨床項(xiàng)目經(jīng)理 25-40k·13薪
      北京-朝陽區(qū) 5-10年 本科
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      年終獎(jiǎng)金 績效獎(jiǎng)金 五險(xiǎn)一金 交通補(bǔ)助 通訊津貼 餐費(fèi)補(bǔ)貼 崗位晉升 帶薪年假 定期體檢 午餐補(bǔ)助
      avator
      陳女士 5天前在線 已認(rèn)證
      招聘主管 · 百試達(dá)
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      職位介紹
      技能要求: 藥品臨床研究 This position’s main responsibility is project management in accordance with company’s policies, sponsor contract/requirements under applicable laws and regulations. This position routine work is plan and Lead the Delivery of all components of a clinical study to time, cost, and quality from study specifications through study closeout activities and/or new drug/product approval by authority accordance with signed company contract with the sponsor. 1. Study delivery ? Planning and leading the delivery of all components of a clinical study to time, cost, and quality per company policies and contract with the sponsor ? Conduct clinical study management related work according to company Standard Operation Procedures (SOP), Good Clinical Practice (GCP), and other authority laws and regulations ? Form a motivated and aligned study team that delivers the study results on or ahead of agreed timeline with high quality & cost-effective ? Work with Line Managers/other managers to identify resource need and secure resources from clinical operations and/or various departments ? Prepare and deliver study execution strategy, including setting study milestone/timelines, develop recruitment strategies, quality control strategies, cost control strategies ? Leading/preparing/contributing/training to the delivery of Clinical Study Protocol, and delivery of other study documents (e.g. Protocol amendments, inform consent form/amendments, site feasibility/selection package files, EC package files, other study files, etc.) ? Produce study trackers, tools, forms and other study specific documents per study needs ? Proactively identify risks to the project, escalate as appropriate and follow through to resolution, develop &manage contingency risk plans to assure timely delivery to quality, budget & time and escalate issues to stakeholders as appropriate ? Leading/managing/contributing/discussing with internal/external study team/members/stakeholder for study status sharing, study reporting, study plan making, documents drafting, issues escalading/resolving/tracking until closed, and/or other stakeholders related activities ? Leading/deciding/participating in the negotiations and selection process of external service providers/vendors per study needs ? Contributes in steering committees, submission assembly teams, regulatory defence teams, contribute to Advisory Boards, and other activities regarding study, if needed ? Develop project management plan from time, quality and cost aspect per company policies and/or sponsor requirements ? Leading/Supporting/approving site selection, initiation, monitoring, and closure activities ? Leading/Supporting/approving study negotiation of budgets and site contracts, if applicable ? Plan, lead and ensure appropriate training is achieved at Investigator/monitor meetings ? Leading/contributing study trainings to team member in specific therapeutic areas, disease, protocol and other study specific processes per study needs ? Track and manage the assigned studies, work closely with study team member to manage the planning, preparation, execution, and reporting of clinical trials ensuring the time, quality, cost & consistency and integrity of data and safety of the subjects ? Focus on end results to be achieved, using metrics, key performance indicators and/or other tools to manage individual and team performance within clinical studies ? Review/approve CRA's monitoring visit reports, conduct accompany site visit, guide/coach CRA resolve issues and other activities during study executions from time, quality, cost perspectives ? Leading/tracking/managing the study Trial Master Files (TMF) were timely and appropriate collected, archived and transfer to sponsor per study requirements ? Leading/tracking/managing the study budget/cost were appropriate applied, arranged, forecasted, paid, invoice collection base on aligned with sponsor and/or company policies ? Acting as monitor per business/clinical trial needs to improve whole team/individual capabilities, efficiency, a clinical trial execution, quality, process initiatives and/or other purposes, if needed ? Conduct any other activities regarding study delivery or line manager assigned 2. Admin works and others ? Participate in Bidding activities and prepare presentation for clinical operation part if necessary ? Interacting with CRM/CTA lead/others for sharing/improving whole team/individual performance/capability and/or other purposes ? In liaison with Line Managers to support individual professional development through mentoring, training and other methods ? Work with other members of the organization to share knowledge, experiences and best practices ? Contributing/leading the whole function develop, quality, process optimization and/or other initiatives, if applicable ? Evaluate application rationality and approve/reject subordinator’s business travel application, and/or other activities per company policies and clinical trials needs ? Conduct any other activities which line manager assigned
      其他信息
      語言要求:普通話
      行業(yè)要求:制藥
      所屬部門:CO部門

      公司簡介

      百試達(dá)(上海)醫(yī)藥科技股份有限公司成立于2010 年,是一家國際化創(chuàng)新藥物臨床開發(fā)機(jī)構(gòu),已連續(xù)兩次榮獲上海市科委高新技術(shù)企業(yè)稱號,服務(wù)范圍覆蓋全國多個(gè)中心城市和區(qū)域,下屬尚睿全資子公司,美國和澳大利亞控股子公司,現(xiàn)有員工已過千人。公司擁有資深專業(yè)研究團(tuán)隊(duì),主要研究人員均具有外資制藥企業(yè)藥物研發(fā)部和臨床研究部工作經(jīng)驗(yàn),具有國際化、標(biāo)準(zhǔn)化的業(yè)務(wù)運(yùn)作流程和科學(xué)嚴(yán)謹(jǐn)?shù)馁|(zhì)量保證體系,諳熟國際多中心臨床試驗(yàn)和國內(nèi)各種類型臨床試驗(yàn)項(xiàng)目的運(yùn)作和管理。公司總部位于上海,在北京、南京、廣州、成都、武漢設(shè)有分支機(jī)構(gòu),在美國波士頓及澳大利亞悉尼設(shè)有聯(lián)絡(luò)處和QA 辦公室。 百試達(dá)業(yè)務(wù)范圍包括臨床試驗(yàn)的設(shè)計(jì)、組織、運(yùn)作和管理,如I-IV 期藥物臨床試驗(yàn)和醫(yī)療器械臨床試驗(yàn)項(xiàng)目的策劃和籌備、方案撰寫、基地篩選、臨床監(jiān)查服務(wù)、藥物管理、數(shù)據(jù)管理和生物統(tǒng)計(jì)、研究報(bào)告撰寫。公司還提供藥品和醫(yī)療器械注冊和醫(yī)學(xué)咨詢和代理、流行病學(xué)觀察性研究、醫(yī)藥市場研究和研究者、CRA 和其他臨床研究專業(yè)人員的培訓(xùn)等。創(chuàng)新藥物研發(fā)包括化合物和大分子生物制品的篩選,活性藥物合成和制劑,化學(xué)藥物和生物藥品的國外專利技術(shù)的國內(nèi)轉(zhuǎn)化以及相應(yīng)的臨床開發(fā)。 此外,百試達(dá)還在臨床醫(yī)學(xué),臨床藥理學(xué)和生物統(tǒng)計(jì)領(lǐng)域擁有一大批專家網(wǎng)絡(luò)資源,并通過高質(zhì)量的各類人員和項(xiàng)目培訓(xùn)不斷擴(kuò)大這一網(wǎng)絡(luò),從而保證各類臨床項(xiàng)目的快速和高質(zhì)量的完成。 公司的合作客戶包括知名跨國制藥公司和醫(yī)療器械企業(yè)、國內(nèi)研發(fā)型制藥企業(yè)、醫(yī)藥科研院所以及專業(yè)學(xué)術(shù)團(tuán)體等。
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