Clinical Developemnt Officer
美国礼来亚洲公司上海代表处
- 公司规模:500-1000人
- 公司性质:外企代表处
- 公司行业:制药/生物工程
职位信息
- 发布日期:2012-11-02
- 工作地点:北京
- 招聘人数:若干
- 工作经验:二年以上
- 学历要求:本科
- 语言要求:英语良好
- 职位类别:临床协调员
职位描述
Job Title: Clinical Developemnt Officer
Department: Medical
Reporting to: Sr. Clinical Development Manager
Salary Class Progression: P1-P2
PURPOSE OF THE JOB
Clinical Development Officer (CDO) is responsible for providing operational expertise to customers through ownership of country and site levels study management. In carrying out this responsibility, the Clinical Developemnt Officer will be responsible for country level implementation starting from feasibility assessment. The CSSM will be responsible for new sites-prospecting, site identification and site selection, for developing and managing institutional and key investigator relationships by serving as the primary interface between Lilly, the investigator and the vendor representatives. The CDO will be also primary communication point for the Clinical Trial Management Associates, including attending PFTs. The CDO will manage specific start-up and study progress related activities.
OBJECTIVES
Business Deliverables:
? Identify, screen, evaluate and develop investigators for clinical trial participation
? Develop and maintain relationships with major institutions
? Development of portfolio sites
? Participates in SD2i meetings to influence timelines and protocol development
? Provides inputs to rALs and study teams on protocol and enrolment feasibility for studies operating in X Country
? Participates in study feasibility assessments (with CRPs) and conducts country enrolment prediction analyses
? Works with GEO and teams to develop enrolment acceleration strategies and track effectiveness
? Initiates and coordinates site selection process
? Coordinates country-specific budget preparation and approval with CBO
? Initiates/coordinates Contracts discussions at the site level
? Coordinates start-up meeting activities including attendees, logistics and agenda
? Coordinates rejuvenation meetings
? Provides project management oversight of country level study deliverables, including tracking of enrolment, resolves enrolment issues, implements enrolment acceleration and patient retention programs
? Meets country level milestones (i.e. FPV, LPET)
? Attends PFT meetings
? Partners with the selected TPO to reconcile enrolment updates as needed
? Coordinates approval of increased enrolment at the country level
Business Development/External Focus:
? Develop and maintain relationships with major therapeutic institutions
? Develop and maintain deep knowledge of structure and content of external enrollment acceleration vendors and data sources as well as interfaces and access to these contacts
? Maintain familiarity with local regulations and guidelines regarding patient enrolment practices
? Maintain active relationships and/or memberships with applicable research and disease-state organizations
Communication:
? Primary interface with investigators, single point of contact for institutions to identify and resolve business process barriers and respond to customer needs
? Interfaces with and builds effective business partnership with Study Teams to understand issues and needs
? Primary point of contact in the country during startup and enrolment phase of the trial
? Provides updates to business partners through effective and timely communication of study status (i.e. newsletters)
? Interfaces with TPO country coordinator regarding development and progress of the study and for specific trial country and site-level issues
? Partners with Clinical Trial Management associate, CDLs, CPCs to implement country/site enrolment and serves as liaison between CTM and TPO at country level
? Responsible for communication flow to CTMs and CPCs regarding trial related information including enrolment status
Process Improvement:
? Actively seeks opportunities for innovative business solutions and implements as appropriate
? Participates in productivity improvement initiatives/six sigma projects
JOB REQUIREMENTS
? Excellent project management skills
? Strong computer skills (i.e. Excel, Word, PowerPoint)
? Strong problem solving and communication skills (both verbal and written)
? Knowledge of clinical research process, minimum 2 years of clinical trial operations experience
? Ability to influence without authority
Department: Medical
Reporting to: Sr. Clinical Development Manager
Salary Class Progression: P1-P2
PURPOSE OF THE JOB
Clinical Development Officer (CDO) is responsible for providing operational expertise to customers through ownership of country and site levels study management. In carrying out this responsibility, the Clinical Developemnt Officer will be responsible for country level implementation starting from feasibility assessment. The CSSM will be responsible for new sites-prospecting, site identification and site selection, for developing and managing institutional and key investigator relationships by serving as the primary interface between Lilly, the investigator and the vendor representatives. The CDO will be also primary communication point for the Clinical Trial Management Associates, including attending PFTs. The CDO will manage specific start-up and study progress related activities.
OBJECTIVES
Business Deliverables:
? Identify, screen, evaluate and develop investigators for clinical trial participation
? Develop and maintain relationships with major institutions
? Development of portfolio sites
? Participates in SD2i meetings to influence timelines and protocol development
? Provides inputs to rALs and study teams on protocol and enrolment feasibility for studies operating in X Country
? Participates in study feasibility assessments (with CRPs) and conducts country enrolment prediction analyses
? Works with GEO and teams to develop enrolment acceleration strategies and track effectiveness
? Initiates and coordinates site selection process
? Coordinates country-specific budget preparation and approval with CBO
? Initiates/coordinates Contracts discussions at the site level
? Coordinates start-up meeting activities including attendees, logistics and agenda
? Coordinates rejuvenation meetings
? Provides project management oversight of country level study deliverables, including tracking of enrolment, resolves enrolment issues, implements enrolment acceleration and patient retention programs
? Meets country level milestones (i.e. FPV, LPET)
? Attends PFT meetings
? Partners with the selected TPO to reconcile enrolment updates as needed
? Coordinates approval of increased enrolment at the country level
Business Development/External Focus:
? Develop and maintain relationships with major therapeutic institutions
? Develop and maintain deep knowledge of structure and content of external enrollment acceleration vendors and data sources as well as interfaces and access to these contacts
? Maintain familiarity with local regulations and guidelines regarding patient enrolment practices
? Maintain active relationships and/or memberships with applicable research and disease-state organizations
Communication:
? Primary interface with investigators, single point of contact for institutions to identify and resolve business process barriers and respond to customer needs
? Interfaces with and builds effective business partnership with Study Teams to understand issues and needs
? Primary point of contact in the country during startup and enrolment phase of the trial
? Provides updates to business partners through effective and timely communication of study status (i.e. newsletters)
? Interfaces with TPO country coordinator regarding development and progress of the study and for specific trial country and site-level issues
? Partners with Clinical Trial Management associate, CDLs, CPCs to implement country/site enrolment and serves as liaison between CTM and TPO at country level
? Responsible for communication flow to CTMs and CPCs regarding trial related information including enrolment status
Process Improvement:
? Actively seeks opportunities for innovative business solutions and implements as appropriate
? Participates in productivity improvement initiatives/six sigma projects
JOB REQUIREMENTS
? Excellent project management skills
? Strong computer skills (i.e. Excel, Word, PowerPoint)
? Strong problem solving and communication skills (both verbal and written)
? Knowledge of clinical research process, minimum 2 years of clinical trial operations experience
? Ability to influence without authority
公司介绍
美国礼来公司(Eli Lilly and Company)是一家全球性的以研发为基础的医药公司,创立于1876年,总部位于美国印地安那州印第安纳波利斯市。2008年礼来全球销售额突破200亿美元,业务遍及全球 143 个国家和地区,雇佣员工四万多人。
礼来于1918年来到中国,将其第一个海外代表处设在上海。在1993年重新回到中国。已成为业界增长速度最快的制药公司之一。至今,我们在苏州拥有一家独资企业:礼来苏州制药有限公司,30多家办事处,员工已超过1400人。 礼来全球研发中国总部也于2008年10月15日在上海张江高科技园区正式成立。
礼来在中国的许多医药领域居领先地位,如抗感染、中枢神经系统、肿瘤、内分泌等。她的创新药物,不仅挽救病人生命、提高了大众的生活品质,同时也为患者、保健提供者和支付方创造了价值,降低了疾病治疗的成本。
作为全球十大制药企业之一, 礼来始终致力于履行企业社会责任。礼来每年投入巨额资金用于回馈社会。由于礼来在企业社会责任方面的突出贡献,礼来已连续三届荣获《商业周刊》杂志“最慷慨的公司”称号。据《慈善纪事》(Chronicle of Philanthropy)显示,在接受调查的91家美国大型公司中,礼来2006年的捐献数量位居第六。2007年礼来公司慈善捐赠总额约为3.15亿美元,其中包括价值约2.4亿美元的产品捐赠,均用于患者援助计划和国际人道主义事业。2007年公司的捐赠总额大约占公司调整后收入(税前)的6%,再次使礼来成为世界最乐善好施的公司之一。
在中国,礼来也积极推动各项社会公益事业,善尽社会责任,致力成为企业公民的典范。2008年礼来公司在华公益投入总计人民币四千余万元。在南方周末2008中国企业社会责任评选中,礼来中国荣膺“2008世界500强企业慈善公益榜”第3名。
礼来公司有着注重内部培养的用人之道,我们愿意招聘处于职业发展初期的员工加入礼来共同成长并长期服务。当公司出现岗位空缺时,我们能够从内部提拔员工任职或转岗。在礼来中国,我们的管理层有95%来自内部提拔。我们还创建了一种注重员工培训与发展的文化和系统。因此,在业界,我们有“礼来大学”之美誉。我们的培训系统,在职辅导系统,和接班人计划尤其为人们所广为称道。 礼来有着注重绩效和行为并重的文化传统,同时为员工提供全面的薪酬福利保障。 我们以最高道德标准管理我们的业务并在日常工作中要求我们所有的员工。我们相信符合最高道德标准的行为将最终使我们的公司和员工受益。
礼来对中国市场有着中长期的发展战略,我们对这个市场雄心勃勃。从2006开始, 礼来公司启动彩虹计划在内分泌, 抗肿瘤及中枢神经领域进行扩招, 我们的员工队伍已增加了40%,达到了1100多人, 为公司的发展做出来巨大的贡献。从2009年到2013年, 礼来将会进一步加大对中国的投资力度, 礼来中国将进行前所未有的扩张计划。
如果你一直想加入这家有着良好声誉的公司, 现在, 机会之门正在敞开!我们寻求年轻的你, 优秀的你, 自信的你加入我们, 和礼来一起共同成长。无论你是经验丰富的专业人士, 还是胸怀壮志的应届毕业生,相信礼来的内部提拔机制和在职培训系统能够给你的职业和人生带来彩虹般的精彩。 如果你够自信, 够优秀,充满对成功的渴望, 来吧,加入我们, 礼来将助你成就梦想!
礼来于1918年来到中国,将其第一个海外代表处设在上海。在1993年重新回到中国。已成为业界增长速度最快的制药公司之一。至今,我们在苏州拥有一家独资企业:礼来苏州制药有限公司,30多家办事处,员工已超过1400人。 礼来全球研发中国总部也于2008年10月15日在上海张江高科技园区正式成立。
礼来在中国的许多医药领域居领先地位,如抗感染、中枢神经系统、肿瘤、内分泌等。她的创新药物,不仅挽救病人生命、提高了大众的生活品质,同时也为患者、保健提供者和支付方创造了价值,降低了疾病治疗的成本。
作为全球十大制药企业之一, 礼来始终致力于履行企业社会责任。礼来每年投入巨额资金用于回馈社会。由于礼来在企业社会责任方面的突出贡献,礼来已连续三届荣获《商业周刊》杂志“最慷慨的公司”称号。据《慈善纪事》(Chronicle of Philanthropy)显示,在接受调查的91家美国大型公司中,礼来2006年的捐献数量位居第六。2007年礼来公司慈善捐赠总额约为3.15亿美元,其中包括价值约2.4亿美元的产品捐赠,均用于患者援助计划和国际人道主义事业。2007年公司的捐赠总额大约占公司调整后收入(税前)的6%,再次使礼来成为世界最乐善好施的公司之一。
在中国,礼来也积极推动各项社会公益事业,善尽社会责任,致力成为企业公民的典范。2008年礼来公司在华公益投入总计人民币四千余万元。在南方周末2008中国企业社会责任评选中,礼来中国荣膺“2008世界500强企业慈善公益榜”第3名。
礼来公司有着注重内部培养的用人之道,我们愿意招聘处于职业发展初期的员工加入礼来共同成长并长期服务。当公司出现岗位空缺时,我们能够从内部提拔员工任职或转岗。在礼来中国,我们的管理层有95%来自内部提拔。我们还创建了一种注重员工培训与发展的文化和系统。因此,在业界,我们有“礼来大学”之美誉。我们的培训系统,在职辅导系统,和接班人计划尤其为人们所广为称道。 礼来有着注重绩效和行为并重的文化传统,同时为员工提供全面的薪酬福利保障。 我们以最高道德标准管理我们的业务并在日常工作中要求我们所有的员工。我们相信符合最高道德标准的行为将最终使我们的公司和员工受益。
礼来对中国市场有着中长期的发展战略,我们对这个市场雄心勃勃。从2006开始, 礼来公司启动彩虹计划在内分泌, 抗肿瘤及中枢神经领域进行扩招, 我们的员工队伍已增加了40%,达到了1100多人, 为公司的发展做出来巨大的贡献。从2009年到2013年, 礼来将会进一步加大对中国的投资力度, 礼来中国将进行前所未有的扩张计划。
如果你一直想加入这家有着良好声誉的公司, 现在, 机会之门正在敞开!我们寻求年轻的你, 优秀的你, 自信的你加入我们, 和礼来一起共同成长。无论你是经验丰富的专业人士, 还是胸怀壮志的应届毕业生,相信礼来的内部提拔机制和在职培训系统能够给你的职业和人生带来彩虹般的精彩。 如果你够自信, 够优秀,充满对成功的渴望, 来吧,加入我们, 礼来将助你成就梦想!
联系方式
- 公司网站:http://www.lillychina.com
- 公司地址:上海市湖滨路222号企业天地1号楼21层
- 邮政编码:200021