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  • 11-09 发布

职位描述

职位描述: ?Acts as primary liaison with client:a)Acts as lead contact for regional and or/project matters.b)Understands/manages/satisfies client contractual, organizational and relationship needs/expectations.c)Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated management plan to client.d)Chairs and leads client meetings.?Leads and directs cross-functional team leaders and third parties/vendors:a)Validates project plan (multi-service plan and communication plan).b)Guides and supports team leads in prioritizing, trouble-shooting and contingency planning.c)Delegates whilst retaining ownership.d)Communicates project specific priorities.e)Liaises with functional leads/managers to optimize performance and utilization of project team members.?Manages project contractual deliverables:a)Supervises progress via metrics.b)Monitors and ensures adherence to the contractual agreement (time, quality/scope, and cost deliverables).c)Leads presentation of internal project status reviews and is accountable for action item follow up.d)Proactively identifies, resolves/mitigates and escalates risks and/or issues.?Manages project costs:a)Owns projections of units/hours (revenue and resources), actual units/hours efficiency analysis.b)Proactively and timely identifies, negotiates and executes contract modifications for assigned projects, ensuring out of scope activities are approved upfront via a contract modification.c)Identifies potential or actual unrecoverable hours and provides analysis and mitigation/resolution plan for senior management’s approval.d)Ensures control of financial risk to PRA.e)In cooperation with the project analyst, applies efficient management of project pass-through costs and investigators payments to ensure all such costs are recovered in a timely manner, and in advance where ever possible.f)Leads presentation of financial reviews and is accountable for action item follow up.g)Ensures adherence to company SOP, policies and guidelines at the project level.h)Assumes project leadership role in compliance at project level to COMPANY processes and systems such as CTMS, ART, eTMF, PSR etc., including escalation to relevant functional and operational management.i)Participation and attendance in bid defense process.j)Mentoring of other members of the project management team or functional leads, as required.k)Provides feedback on project team member’s performance to respective line-managers技能要求:1.Bachelor or above degree with medical/pharmacy or other health-related background;2.At least 7 years experiences of clinical research in pharmaceuticals or CRO companies, and over 2 years related experiences in project management;3.Working knowledge of clinical research procedures and company ctices including local regulatory requirements and GCP/ICH Guidelines for the conduct of clinical studies;4.Strong leadership, organizational, interpersonal and communication skills, with an ability to prioritize and manage work for a team;5.Ability to supervise and delegate tasks and provide clear instruction to others;6.Highly self?motivated and proactive with the ability to work independently;7.Strong problem solving skills with ability to identify potential problems and provide creative solutions to issues surrounding on?time, on?budget and quality delivery;8.Attention to detail;9.Able to communicate clearly & accurately in both written & spoken English. 职能类别: 生物工程/生物制药

联系方式

上海市黄浦区马当路388号SOHO复兴广场A座19层

公司信息

上海康德弘翼医学临床研究公司是药名康德全资子公司,药明康德新药开发有限公司于2000年12月成立,是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司,在中美两国均有运营实体。作为一家以研究为首任,以客户为中心的公司,药明康德向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务,服务范围贯穿从药物发现到推向市场的全过程。药明康德的服务旨在通过高性价比、高效率的研发服务帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。 十多年来,药明康德成功打造了全方位一体化的研发服务技术平台。创建之初,药明康德凭借其在发现化学合成领域的雄厚实力实现了全面发展。近几年来,我们又新增了一系列一体化服务,包括分析服务、生物分析服务、工艺研究、工艺研发服务、API生产服务、药物代谢及其动力学服务、研发生物学、药理学、制剂、毒理学、基因组服务、生物制剂生产服务、抗体及生物诊断试剂的生产和销售服务以及临床研发和产品注册服务等。 从 2000 年 12 月创立至今,药明康德的员工数从4 人增长至 10000 人,实验室由当初仅有的一间增长到近46 万平方米已有及在建研发基地和生产厂房。与此同时,药明康德还在不断增强服务能力,拓宽服务领域,以更好地服务公司持续增长的全球业务需求。作为一家全球领先的医药研发服务公司,药明康德将继续致力于在中美两国为全球客户提供高质量的医药研发服务,帮助研发出更多造福患者的新药及产品。 回望昔年,药明康德已经走过了15年的历程。15年走来,我们见证了新药研发的飞速发展,见证了众多科学家在新药研发中实现梦想,见证了全球2000多家企业攻克越来越多的疾病,见证了越来越多患者脸上渐渐浮现的微笑,同时也见证了药明康德人从无到有将药明康德建成一个无论在亚洲还是在全球医药行业里独一无二的研发生产技术能力平台性公司。 未来我们的发展方向:一是继续将一体化、开放式的研发生产技术能力平台做大做强,继续延揽建立全球最尖端的医药研发技术,包括基因诊断、细胞基因治疗、基因编辑以及一些高端创新药物的研发、生产等。二是更加致力服务中国的大健康产业,通过我们的平台连接“人与健康”,让国际尖端医药技术能为广大国内患者和老百姓所用。 面对2016年,回归成为私营公司的药明康德将更加专注,专注于公司创业之初变革新药研发的梦想。不忘初心,方得始终。药明康德人将继续坚守我们的初心与梦想,在新的征程中,实实在在地推动人类健康。欢迎加入药明康德大家庭,与我们携手一起开启未来,创造未来,享受未来! 如需了解更多,欢迎访问公司网站 http://www.wuxiapptec.com.cn

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