Clinical Project Manager 上海

月薪： 30-40万/年

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： ?Lead one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across the UCB internal and CRO teams.?Articulate study scope, goals and expectations of UCB to the CRO at kick-off and ensure CRO is informed about any relevant sponsor information that may impact the management of the trial throughout the conduct of the trial.?Ensure that the scope, all tasks and responsibilities for a study are appropriately reflected in all study contracts and amendments. Ensure that scope changes are appropriately endorsed and reflected in respective contracts before implementation of activities by the CRO.?Review and challenge CRO's strategy and plans, if appropriate.?Supervise study conduct by regularly reviewing CRO performance through the review of KPIs, metrics and deliverables, with a focus on critical activities that might delay the project, jeopardize quality, and/or impact on budget.?Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO.?Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) / Joint Clinical Study teams and ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence. Findings, including mitigation plans, to be discussed with the CRO and communicated to all appropriate internal and external stakeholders.?Familiarize with the competitive landscape; engage with KOLs, investigational sites, patient advocacy groups and other relevant organizations.?Understand, manage, track and ensure accuracy of study budgets, including the forecast and accrual information.?Work closely with the COL (Clinical Operations Lead), Clinical Project Director (CPD), other team members and stakeholders as required and serve as the internal key contact for their assigned studies.?Closely cooperate with OC&SP and, if applicable, relevant committees/governance bodies and/or CQA regarding the performance and quality of work received from the CROs and other vendors.?Drive the creation of protocol Summaries (including particular emphasis on operational expertise) and consolidate contributions of all team members (may include CRO experts).?Collaborate with members of Clinical Study Team(s) / Joint Clinical Study teams to develop clinical trial protocols and protocol amendments and study documents by providing input and/or approval as defined in SOPs and, if applicable, Strategic Partnership (SP) documents. Ensure that these documents are appropriately updated, e.g. in case new safety information or other change in scope.?Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial and correctly reflect the data and the study conduct, in collaboration with the study team members.?Lead lessons learned meetings as appropriate for assigned studies with internal and CRO team members.?Ensure quality and adherence to the relevant UCB SOPs, GCP, regulatory guidelines and working practices. Support any audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner.?Provide study specific training for internal (i.e. UCB) and external (i.e. CRO, vendors, investigators) team members.?Identify issues/gaps in processes and interfaces with other groups and departments and contribute to developing recommendations for resolution. Contribute to process improvement initiatives, and share best practice experiences with line manager, peers and Partner CROs.?Travel including overnight stays- possibly global - required.?A Senior CPM is expected to mentor other colleagues, present clinical trial related information internally or to an external audience and/or contribute to publications as appropriate.?A Senior CPM may be assigned to more complex studies and/or those with high visibility such as pivotal trials or challenging POC trials, or multiple studies running in parallel.?Perform other tasks as deemed necessary by the Company. 职能类别： 其他

联系方式

上海市黄浦区西藏中路268号来福士广场办公楼2802室

公司信息

比利时优时比制药公司（UCB）始建于1928年，总部设在比利时布鲁塞尔，在英国伦敦Slough和剑桥等地拥有2个研发中心。在八十年的发展中，优时比制药公司致力于为重症患者提供更多的创新治疗方法，造福人类。 优时比制药在全球业务遍布40多个国家，拥有近一万名员工。2010年全球销售收入32亿欧元。全球百强医药行业排名第33位。随着业务的不断拓展，2004年5月，优时比制药完成了对英国生物制药企业--细胞技术公司的收购。2007年9月1日，又完成了对德国许瓦兹制药集团的全球并购。至此，优时比制药公司成功地实现了全球领先的生物制药公司的战略定位。 优时比制药在华机构包括优时比贸易（上海）有限公司和珠海许瓦兹制药有限公司，业务遍及全国，产品涉及中枢神经系统疾病、变应性疾病、心血管疾病、贫血和疼痛治疗等领域。 创新、开拓、诚信、尽责、关爱、包容与业绩是优时比制药公司始终遵循的价值观。 面向未来，比利时优时比制药公司一如既往地秉承特有的业绩、尽责、诚信、包容、关爱、开拓和创新的价值观和企业文化，将建设一个全球生物医药的领先者，首要任务是带来专家和新药，治疗各种严重疾病的患者。 公司网站：http://www.ucb.com 中文网站：http://www.ucb-pharma.cn 为什么选择我们？ 不拘一格的用人之道 公司倡导内部发掘和培养人才，并提倡员工终身学习，鼓励员工不断提高自身的竞争力。每当公司出现空缺时，我们总是优先考虑内部的优秀人才，为有能力的员工不遗余力地开辟职业发展的通道。 卓越完善的人才发展战略 优时比业务的多样性和国际化为其员工提供了广阔的个人发展平台。员工一旦加入我们，就会得到公司在培训、业绩表现和个人潜力挖掘等方面提供的帮助。无论您的专业和职务是什么，您都将对自己的发展前景了然于胸。我们不仅提供正规的培训，而且还通过精良的个人发展计划和在职培训等途径为您的前途指路。 以人为本的管理制度 公司人性化的管理制度不仅体现在对员工职业发展的高度重视，不惜血本的投入，而且更体现在尊重每个人的权利和尊严，集个人和集体的才能和行动以创造我们的竞争优势。 有竞争力的薪酬体系 从长远来看，为了吸引人才，保留人才，并激励人才，我们确保所提供的薪资福利具有市场竞争力。我们期待着员工能有优秀的表现并得到优厚的回报，因而把薪资和员工对公司的贡献直接联系起来。 上海总公司地址：上海市西藏中路268号来福士广场办公楼2802室 欢迎有意向的候选人可将简历投递至邮箱：Ucbcn.hr@ucb.com。应聘简历请在主题中注明申请职位名称。

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