宜昌招聘

JOB TITLE: Clinical Trial Management Officer


JOB TITLE OF DIRECT SUPERVISOR: Manager, Clinical Trial Management

PURPOSE OF THE JOB
The Clinical Trial Management (CTM) partners with the cross-functional study team to develop the clinical strategy/plan and leads the study team in the execution of clinical trials within the clinical plan. The CTM achieves this while ensuring quality, on-time and on-budget fulfillment of deliverables. The CTM supports non-trial, trial and project level assignments within the team.

CORE JOB RESPONSIBILITY
CLINICAL TRIAL LEADERSHIP AND PROJECT MANAGEMENT (LPM-40%; EPM-25%)
? Plans and executes trial level project management activities for assigned studies including trial level timelines, risk assessment, mitigation plans, and other aspects of trial level project management (e.g. budget, grants, metrics).
? Leads study team meetings.
? Develops and tracks overall trial timeline throughout the clinical trial Networks the timeline and gains alignment with global team, affiliates and team members on milestone dates.
? Ensures IMPACT data compliance at the trial level and utilizes Primary Document Owner (PDO) network to achieve country and site level compliance, as appropriate.
? Manages relationships and serves as the focal point of communication between internal and external clinical research partner at the trial level.
? Productively identifies and communicates appropriately the status of ongoing projects, Issues, and risks that may affect the critical path of the clinical trial and project schedule.
? Partners with Sourcing groups, Procurement, and study team to review sourcing alternatives, develop sourcing tools and provide necessary study specific actions in order to obtain reliable study costs, staffing strategy, and timeline projections.
? Provides oversight of CRO performance throughout study implementation.
? Develops study training and may also coordinate/deliver training, as appropriate.
? Obtains clinical trial cost forecasts. Establishes and monitors the trial budget (grant and non-grant).
? Manages and tracks trial enrollment.
? Coordinates proposal reviews with third party vendors, and provides input to Sourcing and Procurement groups regarding needed changes in contract conditions.
? Anticipates, manages, and escalates Issues as appropriate.
? Maintains and archives at trial level documentation.
? Partners with study team in the management of data locks (final and interim) and site closure.
? Partners with CPM in trial-level change controls.

PROCESS EXPERTISE- IMPLEMENTATION AND MANAGEMENT (LPM-30%; EPM-30%)
? Leads the Study Development Process (SD2i) of compound and device trials in direct partnership with affiliates and other medical functions.
? Develops trial level monitoring plan.
? Partners with IMPACT group and affiliate to set up portable (if applicable).
? Contribute to internal governing bodies' reviews and approvals.
? Oversees the delivery of patient narratives.
? Ensures that all study files and business databases are maintained according to policies
and procedures.
? Ensures appropriate and timely completion and submission of clinical trial and regulatory documents at the affiliate and trial levels,
? Consults with Sourcing Group, Global Enrollment Optimization (GEO) and/or regional/affiliate contacts to ensure feasibility of enrollment plan, study design, and understanding of local regulatory approval requirements for successful protocol implementation.
? Initiates and coordinates the process for country allocation.
? Proactively ensures complete documentation for protocol violations, investigator/ERB information, and other elements that are required for the clinical study report or Submission.
? Manages contracts and consultant agreements with external parties and organizations, as appropriate.
? May serve as gatekeeper for external non-clinical research and Investigator initiated Trial (IIT) requests, including facilitation and coordination,
? Partners with Clinical Trial Material Management (CTMM) to ensure proper labeling, creation of drug accountability forms, reconciliation of unbinding summary, and other study CT material issues.
? Ensures inspection readiness and provides consultation and support for any type of audit.
? Ensures trial level safety review is performed.


SITE MANAGEMENT ACTIVITIES (EPM Specific - 15%) (if sites are managed directly by the CTM)
? Partner with Sourcing and Global Clinical 8udgeting and Contracting to Identify, qualify and select sites and initiate contract or LoA.
? Interact closely with the investigator sites plan and implement the trial at each site.
? Ensure comp/lance with the protocol and completion of the trial according to agreed
timelines (including ER8 and Regulatory submissions strategy).
? Work with sites on the creation and approval of informed consent documents.
? Manage Site budget and investigator payments.
? Either perform site initiation,monitoring,and close out visits or co-ordinate these with assigned monitor/CRA. 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

BUSINESS AND OPERATIONAL SUPPORT (LPM - 20%; EPM - 20%)
? Develops and utilizes appropriate study,tracking,and forecasting tools (e.g. budget, timeline projections,enrollment) throughout the trial to make wise, timely, and data-driven decisions while balancing cost, speed and quality.
? Services as the central owner of communication across affiliate(s), functional personnel and CRO, keeping all contacts well-informed of timelines, unanticipated issues, and solutions and actions for which they are held accountable.
? Utilizes critical thinking and problem solving skills to handle assigned projects.
? Holds business partners accountable to agreed upon expectation5 and deliverables.
? Able to articulate and understand the compound strategy and trial priorities in relation to internal priorities and the external environment.

SCIENTIFIC/THERAPEUTIC AREA EXPERTISE, APPLICATION AND SUPPORT (LPM - 10%; EPM - 10%)
? Contributes to the effective design and implementation of clinical strategy, clinical plan, and study protocols.
? Answers protocol and technical questions from customers and business partners.
? Ensure user needs are met in device design considerations and the development of user instructions and training materials, a s appropriate.
? Assists in the development of materials for various committee meetings. May be requested to present on scientific or process-related issues.
? Partners with the Clinical Research Physician (CRP) to present study information at various clinical meeting and therapeutic congresses, as needed.
? Prepares or provides scientific consultation for clinical and regulatory documents such as Investigation Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, interim study reports, final study reports, abstracts, publications and manuscripts.
? Consults and/or drafts responses to questions from Regulatory Agencies and affiliates.
? Assists In the preparation for meetings with Regulatory Agencies.
? Conducts literature searches related to assigned programs.
? Supports and contributes to the development of biomarker strategy.

TRANSFERABLE SKILLS:
? Requires business and technical knowledge within discipline and understanding of key business drivers.
? Makes decisions within guidelines and policies.
? Educates self and others on complex issues and gains support for ideas.
? Provides sound problem-solving skills to complex issues.
? Has impact within related departments or areas.
? May lead small to medium projects or programs with minimal to moderate risks and resource/financial requirements.
? Anticipates customer needs and handles non-standard requests.
MINIMUM 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.
PREFERENCES
? Previous affiliate experience.
? Demonstrated ability to work effectively cross-culturally and in a virtual work environment.
? Strong knowledge of regulations and guidelines that apply to conduct o clinical trials.
? Proficiency in use of Project Management tools such as Excel, MS Project, risks assessments, and contingency planning.

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！