苏州招聘

Purpose:
The purpose of the Associate, Clinical Pharmacology role is to provide input to the cross-functional molecule team on the clinical strategy and plan, and leads study teams of internal and external partners in the execution of studies within the clinical plan. The Clin Pharm Associate achieves this while ensuring quality on-time and on-budget fulfillment of study deliverables. The Clin Pharm Associate may also support non-study project assignments to transform and improve the business.
Key Responsibilities:



1.Study Management
?Plans and executes study management activities including timeline, risk management, budget monitor & control, etc.
?Serves as the focal point of study-level communication between internal and external partners.
?Proactively identifies and communicates appropriately the status of ongoing projects, issues, and risks that may affect the impact chain of the study and project schedule.
?Develops and tracks overall the study timeline throughout the study. Networks the timeline and gains alignment with internal and external partners.
?Leads study team meetings.
?Partners with internal and external partners, including sourcing groups, procurement, and study team to review sourcing alternatives, and provide necessary study specifications in order to obtain reliable study costs, staffing strategy, and timeline projections.
?Coordinates proposal reviews with third party vendors, and provides input to Sourcing and Procurement groups regarding needed changes in contract conditions.
?Provides oversight and/or approval of cross-functional vendor deliverables.
?Partners with Business Management and Clinical Project Management to obtain study cost estimates. Develops the detailed study budget (grant and non-grant). Forecasts and tracks study-level spend. Communicates need for study-level budget change control.
?Anticipates (through detailed risk management planning), manages, and escalates issues as appropriate.
?Ensures execution and approval of data Snapshot (interim and final) in consultation with internal and external partners.
?Manages oversight of study-level documents including study protocols, protocol amendments/addenda and clinical study reports.
?Partners with CPM in study-level change controls to ensure that clinical study deliverables (including data management and medical communications) are delivered with high quality, in scope, and within cost and time objectives.
?Develops and utilizes appropriate study, tracking, and forecasting tools (e.g. budget, timeline projections, enrollment) throughout the study to make wise, timely, and data-driven decisions while balancing cost, speed and quality.
?Serves as the central owner of communication across affiliate(s), functional personnel and CRO, keeping all contacts informed of timelines, unanticipated issues, and solutions and actions for which such personnel are held accountable.
?Utilizes critical thinking and problem solving skills to handle assigned projects.
?Holds business partners accountable to agreed upon expectations and deliverables.
?Integrates compound strategy and study priorities with internal priorities and the external environment to achieve value.


2.Site Management
?Interacts closely with the investigator sites to plan and execute the study at each site.
?Partners with Sourcing to identify, qualify and select sites.
?Partners with Sourcing, Procurement, or Clinical Budgets personnel to develop and negotiate detailed clinical study budgets.
?Partners with Contracts personnel to initiate contracts with investigator sites.
?Ensures compliance with the protocol and completion of the study according to agreed timelines (including ERB and Regulatory submissions strategy).
?Works with sites on the creation and approval of informed consent documents.
?Manages and tracks investigator payments.
?Either performs site initiation, monitoring and close out visits or co-ordinates these with a site monitor. Write or review monitoring reports as applicable and ensure resolution/follow up of data queries and monitoring issues. Escalate unresolved quality and/or performance issues as necessary.


3.Clinical Trial Process
?Provide cross-functional clinical process expertise and input for Critical Chain planning.
?Leads the Study Development Process (SDP) in partnership with internal and external partners.
?Initiates contracts with investigators, consultants and other external parties, as appropriate.
?Communicates study-level requirements to vendors and reviews third party tasks (including data acquisition, dataset requirements, database design) to ensure they meet protocol requirements and other Lilly requirements, and adhere to oversight plan.
?Consults with internal and external partners to ensure feasibility of enrollment plan, study design, and understanding of local regulatory and ethics approval requirements for successful protocol implementation.
?Develops and/or approves (depending on site monitoring sourcing model) study level monitoring plan.
?Develops study training and may also deliver training, as appropriate.
?Plans, manages and tracks study enrollment.
?Ensures appropriate and timely completion and submission of study-level, country-level and site-level regulatory documents to regulatory and ethics bodies.
?Partners with Clinical Trial Materials Management (CTMM) to ensure proper labeling, creation of drug accountability forms, reconciliation of unblinding summary, and other CT material issues.
?Proactively ensures complete documentation for protocol violations, investigator/ERB information, and other elements that are required for the clinical study report or submission.
?Ensures study level safety review is planned and performed.
?Ensures inspection-ready maintenance and archiving of paper and electronic study-level documentation.
?Ensures IMPACT data accuracy and completeness.
?Participates in responses to inspections, assessment and audits.
?Support process improvements and transformational efforts.


4.Scientific/Therapeutic Area Expertise, Application and Support
?Contributes to the effective design and implementation of clinical strategy (including biomarker strategy), clinical plan, and study protocols.
?Answers protocol and technical questions from customers and business partners.
?Ensures user needs are met in device design considerations and the development of user instructions and training materials, as appropriate.
?Contributes to preparation for governance presentations.
?Partners with the Clinical Research Physician (CRP) to present study information at various clinical meetings and therapeutic congresses, as needed.
?Provides scientific consultation for clinical and regulatory documents such as study protocols, Investigation Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, study reports, abstracts, publications and manuscripts.
?Consults on and/or drafts responses to questions from Regulatory Agencies and affiliates.
?Assists in the preparation for meetings with Regulatory Agencies.
?Associate Consultants may also play a leadership role in the development of Clinical Strategy Plan.


Minimum Qualification Requirements:
?Bachelor's degree in a scientific or health-related field.
?Minimum of at least three years clinical research or relevant experience.
?Strong leadership and networking skills.
?Previous experience working in cross-functional teams or projects.
?Strong communication skills.
?Demonstrated problem-solving abilities.
?Strong self-management and organizational skills.


Other Information/Additional Preferences:
?First-hand experience in data management and medical writing activities and processes.
?Demonstrated ability to work effectively cross-culturally and in a virtual work environment.
?Strong knowledge of regulations and guidelines that apply to conduct of studies.
?Proficiency in Excel, MS Project, risk management tools, budget monitor & control tools.

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！