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临床主管以色列飞顿激光有限公司北京代表处北京-朝阳区01-27

学历要求:本科|工作经验:3-4年|公司性质:外企代表处|公司规模:150-500人

任职要求:1.  临床培训及后续临床使用跟踪; 2.   项目临床方案梳理;3. 临床示范中心日常管理及专家观点收集整理。 岗位要求:  1、 本科及以上学历,临床医学等相关专业;  2、 2年以上相关工作经验, 医疗器械行业优先;  3、 具有良好的沟通能力,积极,有热情。

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临床研究员(CRA)北京爱尔默医药技术开发有限公司北京-东城区0.8-1万/月01-27

学历要求:本科|工作经验:1年|公司性质:民营公司|公司规模:少于50人

岗位职责:1、负责临床试验的具体实施和监察工作,确保项目符合国家GCP要求;2、具有临床试验标准操作规程的经验,负责全过程的质量控制和管理;3、负责整理和完善所有试验文档与资料,保证试验文件的妥善保管和归档;4、检查并报告试验进度、质量、和相关问题;5、定期归纳并提交监察报告,填写相关报告及试验记录,确保数据真实准确可靠;6、组织临床试验的启动会及后续各阶段的会议;7、与各研究中心,研究者及统计专家保持良好的合作关系;8、协助各研究中心之间及统计专家之间的沟通;9、协助完成其他相关工作。任职要求:本科以上学历,有相关经验者优先考虑;具有医学、生物制药等相关背景;具有责任感,做事认真细心,有团队意识;具有较好的语言表达能力,沟通能力强。

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临床协调员(CRC)上海瀛科隆医药开发有限公司北京-朝阳区0.7-1.2万/月01-27

学历要求:大专|工作经验:1年|公司性质:合资|公司规模:150-500人

岗位职责:1.收集研究者简历、各中心的实验室正常值、质控证书;2.整理研究者档案夹;3.整理受试者随访表,提醒受试者回访;4.协助研究者整理、粘贴化验单、填写病历;5.协助整理研究者需填写的有关临床试验的各种表格;6.必要时协助研究者寻找潜在受试者;7.协助研究者处理各类问题。岗位要求:1.专科以上学历,护理、医学、药学相关专业,有CRC经验者优先;2.有责任心,细致踏实,执行力强;3.有良好的沟通及组织协调能力;4.熟练使用常用的办公软件;5.一年以上工作经验或具备医院工作经验者优先。

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临床项目经理(PM)奥咨达医疗器械服务集团北京-朝阳区1.8-2.5万/月01-27

学历要求:本科|工作经验:5-7年|公司性质:上市公司|公司规模:150-500人

任职要求:1、临床医学、药学、生物医学工程、统计学等相关专业,专科科及以上学历,具有GMP管理经验;2、熟悉WORD、EXCEL、PowerPoint、Project等办公软件的应用;3、良好的中、英文表达能力;4、本科学历需具有3年及以上的临床试验相关工作经验,1年及以上项目管理经验,专科学历需额外2年的临床试验相关经验;5、对临床试验及国内外临床试验相关法规有一定见解并有的实战经验和技能;6、熟悉医药及医疗器械研发行业商务拓展流程,具有协调沟通及商务谈判能力;7、能够承受30%的差旅工作;岗位职责:1、负责公司医疗器械临床试验的项目管理工作,对所负责的临床研究项目进行全面的质量控制与进度管理,确保所有试验严格按照临床试验方案、标准操作程序/内部操作流程和中国法律法规进行。2、作为临床试验的主要联络人,代表公司及项目团队同申办方、研究者及分包商保持及时有效的沟通,确保项目相关重要信息被准确完整的传递,培养并保持与中心及客户的良好关系3、对所负责的临床研究项目进行全面的质量控制与管理,督导按时完成临床试验在国内的全面启动、执行及结束工作,并及时与所有项目经理及其他部门人员进行沟通和协调,如商务发展,财务行政医学写作,数据与统计,质量保证人员等等4、制定项目管理计划,确定临床研究的职责范围、团队成员,进度计划,财务预算等内容,并在项目进行中不断对项目管理计划进行审核和修改,以确保临床研究满足进度需要,控制项目范围及预算在合同范围内。5、负责与申办方及上级领导及时沟通,对在研及将来潜在项目的选定试验中心、研究者并制定试验预算进行综合考查,定期汇报试验度。 在项目过程中识别、监测并及时应对各种风险,正确评估相应风险对项目的整体影响。6、负责审阅所有项目进行中进行例行质量控制与进展报告、例行访视报告,浏览并处理本项目所有相关的沟通邮件。7、协助CRD及商务部门寻求新项目合作及业务客户拓展,审核报价及相关合同文件。8、具备SCRA的所有职责均能并能及时处理应急突发事件,为SCRA及重要项目经理的主要应急后备人选。9、其它上级领导交办的工作。

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临床监查员北京龙惠科技发展有限公司北京-丰台区6-8千/月01-27

学历要求:大专|工作经验:3-4年|公司性质:民营公司|公司规模:少于50人

  岗位职责:  收集机构信息,按照项目要求筛选研究机构,与机构负责人沟通,确认合作意向;协助医学部经理召开伦理委员会及临床试验项目启动会;负责临床试验的监查工作,对所有文件的真实性进行核查;负责检查并报告试验进度和质量,及时发现问题,并与医学部经理共同分析问题,协商解决方案。        任职要求:  医药、临床、护理相关专业,专科及以上学历;1年及以上相关工作经验,熟悉临床试验管理规范(GCP),有GCP证书者优先;做事认真仔细,善于进行文件审核。      

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临床稽查员荣昌生物制药(烟台)股份有限公司北京-朝阳区0.8-1.5万/月01-27

学历要求:大专|工作经验:2年|公司性质:民营公司|公司规模:500-1000人

职责描述:1、协助QM经理制定并定期更新公司稽查计划,与临床运营和医学部门保持密切合作,协助相关QM/QA计划的完成。2、计划、准备并协助实施内部系统稽查、试验文件稽查( 包括方案、ICF、总结报告及其它相关资料)、研究机构和外部委托业务CRO稽查、完成稽查报告及CAPA的追踪,督促临床相关部门进行CAPA回复及审核。参与药政部门视察前的预备稽查,报告稽查结果并确保被稽查单位采取了适当的纠正及预防措施。3、协助应对药政管理当局的视察和第三方稽查。4、协助QM经理审核批准公司各部门的 SOPs/WPs。5、协助制作、修订公司共通SOPs/WPs并进行相关培训。6、协调其它相关SOPs/WPs、GCP以及适用法规的培训。7、保存公司SOPs/WPs原件、SOPs/WPs培训记录以及其它相关文件。任职要求:1、临床医学、药学、药理、生物科学技术等相关专业,大学专科及以上学历;2、至少2年以上临床开发相关工作经验,有药事注册,品质管理或CRA相关经验者优先,有GMP体系质量管理工作经验亦可;3、理解能力强,处理事务高效灵活,具有很强的沟通和协调能力;4、熟练操作MS-office等常用办公软件,特别是Word,Excel,PowerPoint;5、英语6级以上优先考虑,口语流利,能阅读、翻译、检索外文文献;6、综合素质高,良好的礼仪修养。

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临床监察员(北京)西安新通药物研究有限公司北京-朝阳区1-1.5万/月01-27

学历要求:本科|工作经验:2年|公司性质:合资|公司规模:50-150人

本职位为医学助理职位描述    岗位职责: 1、医学资料的整理和校对工作。 2、完成临床试验相关文件的整理归档。 3、协助完成与临床试验相关的医学写作。     4、英文医学资料的整理和翻译。    5、完成领导安排的其他相关工作。 任职要求:       1、本科及以上学历。       2、医药、病理学、流行病相关专业。     3、2年以上临床试验经验或接受过临床试验全过程培训。 3、英语六级以上,读写俱佳,能完成英文方案和资料翻译。 4、电脑操作熟练,熟练使用常用办公软件。     5、能够根据要求通过搜索工具及文献检索工具完成上级主管的任务。 5、良好的沟通协调能力、具备较强的团队合作精神。 6、健康情况良好。

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临床创新经理 R3546587GE医疗集团异地招聘01-27

学历要求:本科|工作经验:5-7年|公司性质:外资(欧美)|公司规模:5000-10000人

Job DescriptionEssential Responsibilities:Communicate, design and initialize experiment and project in line with GE LCS featured  technologies, to support business Go to market strategy.Discover and propose high-value solutions based on disease-centered clinical requirements, including writing proposals and relevant SCI paper/technical documents writing.Coordinate and deliver application training of AI software developed by the team and realize its value by collaborating with customers on making publications with this software.Work closely with China NPI team to provide clinical input as for novel technology development including digital technology.Work with sales and marketing teams and other functions to leverage the projects to support customer relationship as well as revenue target.Qualifications/Requirements:Medical Doctor degree or excellent master degree, must have ICU doctor working experience. Additional rotation experience in surgery room is preferred.Familiar with medical equipment, preferred with having solid academic project experience with using medical equipment to support clinical, and published high quality papers related to this.Preferred with good record of varied project proposal and paper writing related in critical care and/or anesthesia.Willingness to mixed working contents of hands-on and customer facing communication.Willingness to travel within your specified geographic region as well as nationwide.Strong in reading English literature and good communicate skills in English.Self-motivated, willingness to take the initiative to identify opportunities for improvement and take actions to improve.Have a high sense of responsibility and be able to work independently.

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Clinical Research Manager/临床研究经理罗氏诊断产品(上海)有限公司北京01-27

学历要求:本科|工作经验:8-9年|公司性质:外资(欧美)|公司规模:1000-5000人

WorkdayID: 202011-127805 You will be responsible to pprovide strategic guidance, oversight, and effective delivery forclinicalprograms in area of focus in partnership with cross-functional key stakeholders involved inclinicaldevelopment. participate on cross-functional project teams responsible for theclinicalresearchactivities to support Roche Diagnostic China registration of products developed by Roche Group globally, such as,clinicalsoftware, instrument platforms, assays, reagents, devices, instruments, systems and biomarkers. Foster cross functional relationships to create a cooperative work environment in support of corporate goals. Ensures alignment across studies and lifecycle teams with current regulatory expectations including ensures compliance with the company SOPs, Policies, Directives, Divisional standards, Declaration of Helsinki, Industry standards, relevant GxPs, both CNMPA and/or international requirements and/or best practices. 该职位与参与临床开发的跨职能关键利益相关者合作,为重点领域的临床项目提供战略指导,监督和有效交付。 积极参与跨职能项目团队并负责临床研究活动,以支持罗氏集团全球开发的产品将在罗氏诊断中国注册,如临床软件,仪器平台,检测,试剂,器械,仪器,系统和生物标志物。培养跨职能关系,创造支持企业目标的合作工作环境。确保研究和产品生命周期团队的一致性符合当前的监管要求,包括确保符合公司的 SOP,政策,指令,部门标准,赫尔辛基宣言,行业标准,相关 GxP,CNMPA 和/或国际要求和/或***实践 至完成与研究计划,实施,监测和结束研究相关的所有临床操作。 Main Tasks & Responsibilities主要工作职责 : 1. Planning and executing local studies includesclinicalevaluation,clinicaltrials and/orresearchstudies primarily for non-approved product registration in China and/or may support regulatory registration elsewhere; 提供战略意见和决定参与计划和执行研究包括临床评估,临床试验和/或研究,主要针对中国的非批准产品注册和/或可能支持其他地方的监管注册。 2. Responsible for the implementation and support maintenance of theclinicaltrial-related policies, as well as processes and procedures related to the Design Control requirements; 负责实施和支持与临床试验相关的政策的维护,以及与设计控制要求相关的过程和程序 。 3. Providing input to budgets. Identifying opportunities to reduce costs. May manage portions of larger area(s) budget; 为预算提供想法。确定降低成本的机会。可管理更大面积预算的部分。 4. Managing the trial budgets and timelines and accountable for ensuring that budgets and schedules are met. Managing internal and external resources to support scheduled studies; 管理试验预算和时间表,并对确保满足预算和时间表负责。管理内部和外部资源以支持计划好的研究试验。 5. Ensuring direct reports has the proper materials, systems access and training to complete job responsibilities and are in compliance with regulations, SOPs and protocols; 确保直线汇报人员被提供工作所需资料,系统账号和培训, 符合法规,SOP 和方案。 6. Providing technical expertise to staff for feasibility assessment review and the development ofclinicaltrial documents, IT systems and records (protocols, ICF, data collection forms/plans/reports, monitoring plans, manual of operations, investigator training materials,clinicaltrials report, study forms, templates and monitoring reports, etc.) and trial conduct (oversee central archiving, study supply management, regulatory submissions and CAPA effectiveness, vendor selection). Providesclinicaloperation SOP review and expertise; 为工作人员提供技术专业知识,用于可行性评估审查和临床试验文件,IT 系统和记录的开发(方案,ICF, 数据收集表/计划/报告, 监测计划,操作手册,研究者培训材料,临床试验报告,研究表格,模板和监测报告等)和试验操作(监督中央存档,研究材料供应管理,监管提交和 CAPA 有效性,供应商选择。提供临床操作SOP 审查和专业知识。 7. Maintaining strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners in meeting business goals and ensure operational excellence. Acting as liaison and/or subject matter expert with multiple groups within Roche Diagnostics divisions and other partners to identify, scheduling and implement collaborative studies, regulatory activities, and other programs. Managing relationships with key opinion leaders, laboratory chiefs, investigators and key customers. 与跨职能领导者,主要内部和外部利益相关者以及其他合作伙伴保持有力的协作关系,以实现业务目标并确保卓越运营。作为与罗氏诊断部门和其他合作伙伴内的多个团体的联络人和/或作为专家,以确定,安排和实施协作研究,监管活动和其他计划。管理与KOLs,实验室主管,研究者和主要客户的关系。 Basic Requirements of the Job基本任职资格: You should hold at least Bachelor degree in medical science, preferably inclinicalmedicine, medical laboratory, biochemistry, pharmacology, bio-engineering and biology. 医学专业本科及以上学历,优先临床医学,医学检验,生物化学,药学,生物工程和生物学 You should have: 1. Proficiency in English language skills. Good command of MS office software application; 熟练掌握英文技能,熟练应用微软办公软件 2. Understand pharmaceutical and/or medical device regulation and ICH/GCP; 了解药品及/或医疗器械法规和ICH/GCP 3. At least 8 years of working experience inclinicalresearch,clinicalproject management, data management inclinicalmedicine, CRO, pharmaceutical, Medical Device, or in-vitro Diagnostics industries. Two-three years of project management or people management experience is a plus but not prerequisite. 临床医学,CRO,制药,医疗器械或体外诊断行业至少 8 年的临床研究,临床项目管理,或临床数据管理相关工作经验,两到三年的项目管理或人员管理经验尤佳。

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Country Study Manager罗氏(中国)投资有限公司异地招聘40-50万/年01-27

学历要求:本科|工作经验:8-9年|公司性质:合资|公司规模:500-1000人

Main Accountabilities and Responsibilities: Throughout the Study Lifetime: ? Has full accountability for all assigned studies at Regional/country level (Global and local studies) including adherence to quality, timelines and budget. ? Leads local study teams, represents Country/Region Clinical Operation at the global SMT, and provides Global Teams with feedback from a local CCO perspective (Global Studies). ? Leads the local study team, including cross functional group leaders, and ensures GLORA process is followed (Local Studies), if apply. ? Coaches, and provides indirect line management support in partnership with the relevant line managers to Roche in-house study team members (i.e. Country Study Specialist (CSS) and Study Start Up Specialist (SSUS)) by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow up to ensure team performance is fully optimized. ? Provides oversight, leadership and support to CRO staff (ie Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)) to ensure overall delivery at the country and site level (time, quality, cost) and interfaces regularly with local Roche Vendor Manager and CRO Management regarding feedback on CRO staff performance. ? Collaborates in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow up. ? Actively conducts risk management activities (assessment, measurement and mitigation) on an ongoing basis in order to ensure overall delivery at the country and site level (time, quality, cost). ? Identifies areas of best practice and contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function. ? As requested by local Head of Clinical Operations and/or Therapeutic Area Leaders (TALs) and/or Country Medical Director participates in overall TA support in area(s) of expertise eg future landscaping activities, investigator/site development activities etc Study Preparation Phase: ? Leads and participates in the preparation phase of the study (feasibility, site selection, initiation) ensuring all other roles that support these activities both within Clinical Operations and externally contribute appropriately. ? Provides support and expertise for regulatory, ethical and administrative submissions. ? Accountable for ensuring investigator site recruitment targets and timelines are realistic and adequate to ensure recruitment to overall country commitment and developing and actively managing study patient recruitment strategies. ? Accountable for the development of the local CCO’s study budget, initial study resourcing forecasts and establishment of study level plans. ? Accountable for ensuring that TMF (country and site level) documentation is Inspection Ready by ensuring there are regular quality checks on the completeness and robustness of study related documents. Study Conduct Phase: ? In accordance with the overall project plan, manages and maintains accurate country/study level plans (i.e. timelines, budget, resource, risk and quality plans) in appropriate Roche planning system. Highlights deviations in plans to relevant parties, develops and implements mitigation strategies as required. ? Develops and maintains effective working relationships, including being the key point of contact where appropriate, with key internal and external stakeholders, including investigators, local medical team, global study team, other local departments, external vendors/CROs etc. ? In conjunction with local Head of Clinical Operations, Therapeutic Area Leader (TAL) and/or Medical Manager (MM) or the Country Medical Director (CMD), ensures relationships with key investigator sites, alliance partners and/or collaborative groups are optimized to ensure efficient and smooth conduct of the study. Study Close-Out: ? Ensures all activities related to site/study close-out are managed according to global and local processes. ? Manages either directly or indirectly knowledge sharing activities via debriefs or other focus group activities. Qualification:Education and relevant working experience: University degree or equivalent in a medical/science-related field and/or 5 years proven experience in Clinical Research/Development or related industry. Skills, Experience and Competencies: ? Leadership: developed through leading multi-functional matrix study teams through all stages of clinical studies ? Project Management: including implementation of risk management plans and management of complex study budgets and resourcing plans ? Communication: excellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to all levels in the organization ? Personal Organization: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven. ? Good knowledge of ICH GCP, GPP, Roche SOPs/Guidelines and quality standards related to study management. ? Clear and accurate communication in written and spoken English. ? Strong computer skills. ? Clinical development experience on the operational aspects of conducting clinical studies including: ? vendor/CRO resource management ? leading/working as part of a development team ? implementing clinical development plans ? risk management ? coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units ? Demonstrated ability to interact with different professional levels of the research community ? Experience of influencing and negotiating at all levels to achieve team delivery Other: ? Availability to travel domestically and internationally if required.

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Associate Director, PK Expert拜耳医药保健有限公司北京01-26

学历要求:博士|工作经验:3-4年|公司性质:合资|公司规模:500-1000人

工作职责Independently representing TSA in China Project Teams to provide TSA strategy (including contributing to the CHGRAO strategy) to global and China development programs, provide clinical pharmacology expertise in potentialin- /out-licensing opportunities  Being responsible for content and timely provision of clinical  pharmacological documents such as IB, IMPD, study protocols, PSUR  reports, study reports, IND documents as well as publications, when appointed as CPL, or independently providing PK contributions to these documents when appointed to the project or individual studies.  Additionally for China studies, contributing to the translation  verification of protocols, CSRs, briefing documents, andother TSA-related documents supporting China EC/CHGRA/CTA/NDA filings    Representing TSA externally, e.g. in meetings with authorities or key  thought leaders    Providing PK and/or clinical pharmacological advice and expertise to  independently design, plan, execute and evaluate appointed clinical pharmacological as well as clinical studies in close collaboration with  the study teams    Inspecting, evaluating and reporting new results within the context of  development projects. Drawing consequences from new results/critical processes, adapting the project plan by implementing appropriate  measures to avert risks within the context of the drug development    If appointed as CPL, -leading the Translational Medicine (TM) team and representing TM in  Global Project Teams and related clinical teams.  -creating, updating and implementing the clinical pharmacology project  development plan (generally after D6) or contributing to it and  presenting it to decision-making committees  Being responsible for coordination of all clinical pharmacology activities related to preparation and submission of dossiers (NDA) and a state-of-the-art label (in case of the TSA representative this applies mainly to the China related activities)  Actively participating in specialist conferences, seminars/relevant  educational events and taking into account the state of scientific  knowledge and publications, local and international authority  guidelines / requirements and in-house regulations (e.g. SOPs). Support  the head of TSA in global review of clinical pharmacology related   任职要求Master's degree in Clinical Pharmacology orrelevant scientific field  with 4 or more years of experience in PK and in clinical pharmacology Adequate knowledge of China regulatory environment and guidelines related to clinical pharmacology and clinical development (in particular CDE, CHGRAO as well as Ethics Committee) Experience in drug development and in applying PK and biopharmaceutical principles and methodologies of advantage Experienced in working as part of a team and willing to gain capabilities in directing teams and ideally experience in working with  global teams Capable of working independently and on own initiative Advanced communication and organizational skills, including the ability to handle conflict and awareness of cultural differences Interest in interdisciplinary work Efficient analytical thinking and working methods, awareness of responsibilityVery good knowledge of written and spoken English and Chinese

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Associate Director, Clinician(J16271)辉瑞制药有限公司北京-东城区5-6万/月01-09

学历要求:本科|工作经验:10年以上|公司性质:外资(欧美)|公司规模:5000-10000人

工作职责:The China Clinician is responsible for high quality and timely delivery of one ormore interventional clinical trials for a Global Product Development /Global Established Pharma medicine.They applytechnical excellence in the design of cost-efficient clinical trials to meet the needsof internal and external customers, ensure effective conduct and medical/scientificoversight of studies (in partnership with Development Operations) and supportappropriate interpretation and communication of clinical trial data (including highquality regulatory submissions and product defense activities). They ensurecompliance with internal and external standards, proactively mitigate risk andmanage emerging clinical issues.The China Clinician may act as a site liaison and point of contact to expedite studystart-up and conduct and to support clinical training, compliance and overall studyquality.Depending on the program, the China Clinician may manage a group of 1 to 5C h i n a Clinicians.任职资格:At least ten years experience in Vaccine research.

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CRA临床监查上海任仕达人才服务有限公司北京0.9-1.4万/月12-25

学历要求:大专|工作经验:2年|公司性质:外资(欧美)|公司规模:150-500人

职责描述: 1、根据公司政策和SOP的要求,协助主管建立和维护公司培训系统及流程; 2、协助质控主管建立内部质量控制计划,按照质量控制计划的要求,完成所需的质量控制工作; 3、协助参与制定或审阅项目特定质量控制计划及风险管理计划; 4、根据要求定期向上级领导提供质量评估数据(内外部稽查发现,视察发现,质量控制中的发现)的分析; 5、负责指导CRC处理试验过程中遇到的质量问题; 6、完成领导交予的各项工作。 任职要求: 1、大专及以上学历、护理学、药学、临床等相关专业毕业; 2、掌握较好的GCP及专业知识(心内科相关经验优先); 3、1-2年CRA或临床试验质控工作经验; 4、有1-3个完整项目的质控/监查经验; 5、具有较好的沟通协调能力及应变能力,能处理工作中遇到的各项紧急事务; 6、有团队协作意愿,愿意分享相关经验,能理解并接受任务安排; 7、能够独立思考、有主动发现问题并及时解决问题能力。

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医学事务总监(创新药方向)华润双鹤药业股份有限公司北京-朝阳区3-5万/月12-22

学历要求:博士|工作经验:5-7年|公司性质:上市公司|公司规模:10000人以上

岗位职责1、参与创新药的立项评估工作;2、负责创新药临床试验的设计、组织和实施;3、与行业内专家建立良好的关系4、跟踪国内外创新药临床研究进展,定期组织医学部内部对已开展的项目进行风险评估。5、负责某一领域内药品创趋势及新药动态的持续评估工作。6、审核临床研究过程中的关键文件7、负责内部专业知识的培训任职资格任职资格1. 临床医学、临床药理或基础医学博士研究生,5年以上医药研发工作经验。2.负责过创新药的临床试验设计或实施。3. 具有心血管、糖尿病领域创新药经验者优先。4. 熟悉国内外药品研发的相关法规及指导原则。5. 良好的英文专业写作能力。

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北京注册临床部SCRA上海医药集团股份有限公司北京01-27

学历要求:本科|工作经验:2年|公司性质:国企|公司规模:10000人以上

岗位职责:1、负责新药临床试验的组织、试试和监查工作,确保临床试验严格按照GCP、SOP试验方案和相关法律法规进行;2、负责调研、提供试验中心和研究者相关信息,并根据试验进度及时更新;3、协助在项目计划时限内获得各项临床试验文件及伦理委员会批件;4、组织筹备和参加研究者会议并在会上做会议记录;5、管理所负责的研究中心试验物品,包括试验用药、试验文件及试验的相关设备;6、协调中心稽查签的各项准备工作,制定整改计划,并按时完成整改计划的工作。岗位要求:1、本科及以上学历,英语四级及以上,临床医学、基础医学、护理学、药学及医学药学相关专业;2、工作经历:需有上市前注册项目药物临床试验经验,至少有两年及以上申办方或CRO公司SCRA经验; 3、熟悉临床试验监查、NMPA法规、GCP条例;4、熟悉Microsoft Word、Excel和PowerPoint等熟练使用各种办公软件及设备;5、善于与他人沟通,有良好的表达能力以及较强的谈判、应变能力。

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临床运营总监葵花药业集团股份有限公司北京50-60万/年01-27

学历要求:硕士|工作经验:10年以上|公司性质:上市公司|公司规模:10000人以上

职责描述:1、为在研开发项目制定里程碑、时间节点及工作流程,确保按期完成里程碑事件和工作目标;2、负责研发项目临床及非临床实验的全过程,包括方案制定、临床试验基地选择、项目有效实施和质量控制等;3、负责与药物临床研究相关的关键审评专家、临床专家和其他临床研究资源沟通和交流,协助制定正确的临床研究战略和方案,从而保障临床研究的顺利进行;4、负责临床试验总结、审核,组织临床研究会议,临床试验审批等;负责管理并沟通解决与开展临床研究有关问题;5、负责临床团队的构建和培训管理体系,建立并定期完善临床运营相关的制度流程。任职要求:1、医学、药学、生物学等相关专业硕士及以上学历;2、熟悉ICH-GCP、GCP及相关注册法规的要求;具备优秀的领导、决策和判断能力,良好的管理能力和沟通能力;熟悉药物研发过程,熟悉中国、欧美日法规要求,有双报经验者优先;有国际制药公司或CRO公司相关工作经验者优先;3、8年以上临床研究工作经验 ,5年以上临床研究管理工作经验;,负责过至少两个创新药或进口新药的临床申报工作。执行力、学习力、计划能力、分析能力 、谈判能力、组织协调能力 、资源整合能力

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高级医学事务经理-麻醉手术方向费森尤斯卡比(中国)投资有限公司北京2.5-3万/月01-27

学历要求:硕士|工作经验:5-7年|公司性质:外资(欧美)|公司规模:1000-5000人

岗位职责:a)    Lead team to support pre-marketing studies: design, draft and finalize clinical study protocols; provide scientific supports during whole study period; draft and finalize clinical study report as required by global and local authority on timeb)    Lead team to provide medical supports to BU: including newsletters/medical stories, advisory board meetings, KOLs development, CMEs, scientific reviews (such as promotional materials and other scientific materials), publications, post-marketing trials, etc.c)     Lead team to develop relationships and engage KOLs in scientific activities that differentiate FK as a scientifically driven healthcare organization.d)    Lead team to manage the clinical communication and training activities of the business, so as to create a superior clinical brand and quality perception of products and services.e)    Lead team to provide scientific support to BD/RA/MI/GA/CMA and other departmentsf)     Provide on-job training to team members, provide other medical trainings if necessary. Team turnover rate less than 25%g)    Make sure of full compliance for team任职资格:工作经验: 1.  Medical master degree or above in clinical medicine2.  More than 3 years’ experience as a clinical doctor3.  More than 10 years medical affairs working experience in pharmaceutical company, international company is preferred.4. More than 4 years MA team leader experience in pharmaceutical company, international company is preferred.专业:More than 3 years of clinical experience in relevant department.其它知识和技能:1.      Team management skill2.      Strategic planning capacity3.      Competence in solving complicated problems4.      Fluent in oral/written English

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高级医学专员深圳信立泰药业股份有限公司异地招聘30-40万/年01-27

学历要求:硕士|工作经验:2年|公司性质:上市公司|公司规模:1000-5000人

工作职责:1、根据公司立项,负责撰写研究者手册、综述、说明书、临床研究总结报告等,独立完成撰写或者审批医学文档(如服务规范、方案、ICF、CRF、CRF填写指南、病人日志等),以及负责或协助解答医学问题等;2、负责或协助组织临床研究项目的方案讨论会,启动会,中期会等医学相关会议;3、负责或协助进行研究项目SOP的撰写;4、负责公司项目的医学监察及与各PI的医学事务沟通;5、对项目经理及参与项目的临床监查员、CRC等进行临床方案的培训及监管;6、参与或协助项目的稽查及质控工作;7、与临床研究监管机构的沟通和交流,对其提出的问题做专业的回复和解答;8、协助注册部门完成临床注册等注册资料撰写;9、其他临床研究医学事务或其他交办事务。任职资格:1、硕士研究生,具备在制药企业或CRO公司临床部门的2年以上工作经验,具备医院临床工作经验优先;2、了解临床医学和临床药理学相关专业知识;了解临床试验工作并具有较好统筹协调能力;3、了解新药研发流程(包括CMC、临床前及临床等相关背景知识);4、了解国内外新药临床研发相关法规和指导原则。5、熟练掌握GCP、ICH-GCP政策法规知识,熟悉行业内指南和指导原则;6、较好的文案功底,CET-6,office软件的熟练应用

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注册临床部经理健帆生物科技集团股份有限公司北京-丰台区40-70万/年01-27

学历要求:本科|工作经验:8-9年|公司性质:上市公司|公司规模:1000-5000人

岗位要求全日制本科或以上学历,临床医学相关专业,8年以上相关工作经验;熟悉临床试验相关的各类法规,熟悉国内外临床研究发展与现状;精通临床试验流程及工作内容,有上市前临床试验经验优先;具备良好的逻辑思维/沟通协调/团队组织能力及项目管理能力。                岗位职责 依据医疗器械GCP及NMPA法规要求,建立临床试验操作规程,并适时优化完善; 及时获取医疗器械法规动向,明确国家法律法规要求,保障临床试验全过程严格执行,确保临床试验合法合规、安全有效; 临床试验全面质量控制及管理,督导临床试验严格按照方案执行;沟通临床项目经理及其他内部人员,协调解决项目问题,督导按时完成临床试验的启动、实施及结束;统筹项目预算,保障费用支出合理性;审核部门临床试验相关文件,保障试验文件科学性及合规性。    工作地点:北京总收入=年薪40-70万 + 股权和期权 + 优厚福利

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医学经理(上市后)昆药集团股份有限公司(原昆明制药)北京-朝阳区01-27

学历要求:硕士|工作经验:3-4年|公司性质:民营公司|公司规模:1000-5000人

岗位职责:1.协助上级制定产品上市后临床研究的策略和计划。2.协助上级或独立主导产品临床研究,设计研究方案,管理临床研究,起草或审核研究报告,并制定发表计划。3.遵循公司规范,熟悉和了解GCP,ICH等法规和指导原则,严格保障研究的质量。4.协助或独立进行有效的KOL管理,协助开展专家咨询会等工作。5.支持公司的内部医学培训和推广资料的医学审核工作。6.收集治疗领域的进展和专家学术需求信息,与目标专家进行专业性沟通。7.协助上级或独立进行其他医学项目(药理,毒理,专利合作)的前期立项尽调,中期项目合作方的筛选和执行管理,结束后的总结汇报等工作。8.完成上级交办的其它医学相关事宜.9.定期(或及时)向部门负责人汇报工作实施情况。任职要求:1.硕士学历,临床医学、临床中医学、临床药学等专业毕业,神经内科、麻醉科、中医、中医脑病等相关学习和工作背景优先;2.有CRO公司的项目经理、CRA、医学经理等工作经历;3.较强的逻辑思维、沟通协调能力,能够与公司内部其他部门和外部合作方能够保持良好的沟通,获得支持,积极推动医学项目的进度;4.较强的执行能力、团队合作能力、抗压能力,可以适应频繁出差;5.CET6级以上,能熟练查询和阅读国内外文献资料;具备较好的文案写作能力;6.有较好的职业稳定性。

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