苏州 [切换城市] 苏州招聘苏州生物/制药/医疗器械招聘苏州医药技术研发管理人员招聘

临床项目管理官员clinical project management 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:2013-06-20
  • 工作地点:上海-卢湾区
  • 招聘人数:1
  • 工作经验:三年以上
  • 学历要求:本科
  • 语言要求:英语熟练
  • 职位类别:医药技术研发管理人员  临床研究员

职位描述

PURPOSE OF THE JOB
The purpose of the Clinical Project Management Associate (CPM associate) is to lead the application and integration of key Clinical Project Management processes and tools across clinical teams and/or subsets of clinical teams to deliver clinical milestones on time, on budget,and within scope. Primary responsibilities include leading the creation of an integrated clinical development plan or subsets of the plan including scope, budget,timeline, and risk that translate the "label as driver" strategy into operational objectives as well as monitoring performance vs. plan and leading appropriate control processes for the team(s). In addition, the Clinical Project Management Associate is responsible for working with others on the team to manage third party relationships (including partnerships) related to clinical development, effectively managing communications, resolving issues, ensuring documentation of key clinical information and decisions,and ensuring project management and clinical systems are accurate and up to date (MS Project, SAP, IMPACT etc.).

CORE JOB RESPONSIBILITIES
The Clinical Project Management Associate leads the implementation,application, and integration of standard clinical project management processes and tools. These project management processes and tools include but are not limited to the development, monitor, and control of integrated clinical scope, timelines, budgets, risk management plans, and communication plans. In addition,the Associate leads communication of the results of these processes to customers, stakeholders, partners,and leadership and influences quality decision making by translating results into actionable options/scenarios. Other specific activities in this area include:
SCOPE
? Provides input on strategy for implementing clinical plan, developing realistic project milestones and deliverables, and linking clinical plan to the Draft Launch Label
? Leads team to develop and maintain appropriate clinical scope documentation; update clinical plan at least annually, or after governance visits, major modifications in scope, resources or timeline and secure team/leadership alignment around the new clinical plan.

TIMELINE
? Develops and maintains up-to-date clinical plan timelines (using ProChain or Microsoft Project) and process maps (if appropriate).
? Identifies, communicates and manages the critical path/chain and leading indicators of the team's progress to major clinical milestones.
? Monitors and reports performance to both plan and QSV goals and drive team action when plan is not being achieved.
? Drives clinical project meetings or other appropriate forum to prospectively manage upcoming team-related activities, key milestones, and decisions as well as to proactively identify updates to clinical schedule;
initiate clinical schedule updates on a regular basis and revise schedule as appropriate.
? Drives data completeness and accuracy within business systems by team, functions, and regions.

BUDGET
? Works with financial, functions, develops and manages the overall clinical budget for the team.
? Reviews grant and non-grant actual data across overall plan on a monthly basis for clinical teams to identify any potential trends in spending. Consult with Clinical Operations Team to understand variances to the plan/forecast and reasons for the discrepancies. Drive re-forecast grant and non-grant expenses with the Clinical Operations Team when necessary.
? Provides the team and leadership an understanding of the cost of development options.
? Identifies opportunities for external sourcing (link with Medical sourcing function).

RISK MANAGEMENT
? Leads the development of clinical team plan/risk assessment and mitigation/contingency planning.
? Communicates clinical risk assessment and mitigation/contingency plans within team and to functions,
affiliates and management; ensure risk owners are assigned.
? Proactively identifies and communicates to the team the risks that may affect the clinical critical path.
? Hold clinical risk owners accountable for monitoring and reporting status of risks; lead implementation of mitigation/contingency plans.

CHANGE CONTROL
? Leads the development, management, and communication of the clinical change control process and outcomes for team/project

COMMUNICATION & TEAM MANAGEMENT
? Influences and works with quality mindset across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources and timeline; ensuring accurate collection and communication of clinical metrics; may ensure when appropriate, the archival of all relevant clinical information at the termination of a project and as appropriate throughout the project.
? Ensures coordination of clinical meeting logistics and provision of timely meeting agendas and meeting minutes
? Builds and maintain effective clinical teams; motivate, recognize, coach & mentor study team members and associates.
? Supports the Advisor, Clinical Project Management to effectively manage partnership and
interactions/integration with clinical team (if applicable).
? Identifies the critical clinical decisions that must be made by the team and ensures the key technical experts are actively involved in making those decisions. Drives clinical decisions to resolution. SUBMISSION PLANNING AND EXECUTION (if applicable for the phase of project)
? Leads a cross-functional clinical submission operations team. Serve as a point person for all clinical functional area deliverables related to the submission.
? Provides critical evaluation of submission strategy, including (where applicable) strategy for countries to submit in and their relevant submission packages. Planning for clinical support of regulatory agency meetings, consultant board/advisory meetings, new formulations and new indications.
? Establishes and drive the overall clinical submission plan and timeline including critical path management, track progress against timeline, and drive resolution of issues to meet submission milestones.
? Ensures alignment of the Table of Contents developed by Regulatory Affairs Global Operations and Regulatory Scientists and Clinical submissions plan.
? Drives with cross-functional team members the planning and preparation of team clinical dossier specific documents (i.e., clinical overview and clinical summary).
? Responsible for planning and coordinating clinical activities in support of the regulatory approval process: regulatory response, label negotiations, and advisory committee preparations.

CAPACITY PLANNING/MANAGEMENT (if applicable for phase of project)
? Provides risks assessment on the clinical resource plan created by the Medical Functional Manager/Team Leaders.
? Proactively reviews project timelines, determine critical path and, by continually assessing any changes in peak workload, will notify Medical Functional Manager/Team Leader of forecasted resource overloads that will affect critical path activities.
? Through conducting risk assessment and creating contingency plans for clinical projects, will immediately understand the impact of any "roadblocks" that may affect timelines
? Assesses impact of clinical scope changes and provide recommendations to the team regarding the resource/budget implications of these changes.
? Provides necessary clinical plan information and updates to functional manager/team leader and capacity planners to enable effective and accurate capacity planning for team/project.

APPLICATION / IMPROVEMENT of PROCESS (Shared Learning) 20%)
The Clinical Project Management Associate plays a leadership role as a resource to the business with regard to shared learning, process improvement, and identification of special /complex needs as they pertain to their primary responsibilities.
? CPM Associates must understand the principles of Critical Chain Project Management and will monitor and Job Description – Senior Associate, Clinical Project Management (P2) 4/6
Clinical Project Management, Asia Pacific control projects utilizing this methodology". They may receive certification in Critical Chain project Management.
? Generates ideas for new processes and process improvement within Medical to enhance function of team. Works with medical functions to implement new clinical processes within Medical and the team.
? Ensures the utilization and consistency of documented processes of Medical; may serve as a consultant to the team in executing clinical operating procedures.
? Identifies and shares learning opportunities and process improvements with the team and function in order to streamline the effectiveness/efficiency of conducting clinical trials; identify methods to decrease clinical cycle times.
? Reviews databases utilized across Medical and Project Management and recommend ways of streamline tracking, link database or eliminate duplication of efforts.
? Liaises with Project Management Excellence (PME) to identify,share,and incorporate best practices into future iterations of processes, tools, training, or guidance.
? Represents CPM on cross-functional teams (e.g., Six Sigma) and represents output from those teams to CPM, AP and/or CDO leadership. May also support Due Diligence projects
? Seeks input from people with First-hand knowledge of issues,along with gathering data on past projects, etc. to help determine best future options for the project.
? Leads and participates in retrospective project/process review meetings (i.e. after action reviews) to identify issues and strengths and help capture and implement learning.
? Assures that shared learning is placed on shared learning databases and/or other appropriate locations for easy access.
? Actively participates in Project Management Peer Review Sessions.
? Drives compound Feasibility Reviews to ensure on time and on budget delivery of the clinical plan

PEOPLE (10%)
? Reaches agreement with supervisor on the alignment of their performance and development objectives with the goals and objectives of the department and the corporate business.
? Models the leadership behaviors put forth in the "On Leadership" White Paper.
? Is an ambassador for the Lilly Brand.
? Contributes to the development of others by being an active source of coaching and feedback to co-worker.

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 degree,preferably in a scientific or health-related field.
? Minimum of 2 to 3 years of directly related clinical trial experience or relevant clinical development experience with a strong knowledge of regulations and guidelines that apply to the conduct of clinical trials is strongly preferred.
? Must understand clinical drug development processes and the interdependencies of various tasks that require coordination among teams, functional groups, and regions.
? Ability to work across functional and geographical boundaries in order to develop strategies and plans,and deliver results.
? Demonstrated knowledge and experience with project management tools and processes (e.g. management of integration, scope, Time, cost, quality, human resources, communications, risk and procurement as defined by Project Management Body of Knowledge.

PREFERENCES
? Higher degrees, certifications (M.S., PMP) preferred.
? Consistent demonstration of leadership behaviors and ability to influence others related to the Associate level.
? Strong self-management and organizational skills; able to manage workload,set personal and team priorities and adjust as needed.
? Effective interpersonal and team building skills; proven ability to develop effective teams with diverse interpersonal styles; able of deliver effective coaching and feedback.
? Able to anticipate change,shows flexibility, adjusts quickly and effectively to frequent change and altered priorities.
? Strong computer skills; skilled at using Word, Excel, PowerPoint, ProChain and Microsoft Project; capable of maintaining the appropriate project documentation.
? Strong problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent recurrence within the team.
? Strong communication skills; able to communicate clearly and succinctly with team members and leadership.
? Ability to influence others without direct 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!

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