延吉招聘

Job Responsibility:

· Lead one or more multi-functional Clinical Study Team(s) or oversee the activities of the operational Clinical Study Team(s) at Partner. In Partnered trials, leading the Joint Clinical Study Team composed of UCB and Partner team members.

· Work closely with the CPD and other team members as required and serving as the key contact for the assigned studies.

· Operationally coordinate and manage or provide oversight of the Partner for clinical studies including but not limited to:

· contingency planning,

· tracking and management timelines

· ensuring Clinical Trial Management System (CTMS) reflects the current trial status

· ensuring the TMF reflects current trial status

· providing clear, accurate and timely information flow and status updates internally and externally as required

· selecting and managing vendors as applicable

· Regularly review CRO/Partner performance, as applicable, through regular meetings, review of status reports, KPIs, metrics and other deliverables. Findings to be communicated internally within UCB as appropriate and all issues to be followed-up in a timely manner. Closely cooperate with O & C and if applicable relevant committees/governance bodies and/or CQA regarding the performance and quality of work received by vendors.

· Track and manage budgets (e.g. forecasting)

· Represent (Joint) Clinical Study Team(s) as active member of Clinical Subteam.

· Ensure adequate participation, contribution and accountability of the study team members or the oversight of these duties performed by the Partner Project Manager.

· Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices.

· Ensure that the study is audit/inspection ready at all times and any result findings from audits/inspections are addressed appropriately and in a timely manner or the oversight of these duties performed by the Partner Project Manager.

· Provide input to the development of Study Concepts and drive the creation of Protocol Summaries (including particular emphasis on operational expertise) and consolidate contributions of all team members (may include Partner experts).

· Collaborate with members of Clinical Study Team(s), Clinical Subteam or Partner to develop clinical trial protocols and protocol amendments.

· Collaborate with members of Clinical Study Team(s) to develop study documents (e.g. Informed Consent Form/Patient Information, CRF, Monitoring Guidelines, data cleaning plans, statistical analysis plans, vendor contracts) either directly or in case of partnered trials by providing input and/or approval as applicable.

· Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial and correctly reflect the data, in collaboration with the UCB and/or Partner Clinical Study Team Members and the Clinical Subteams.

· Provide study specific training for internal (i.e. UCB) and external (e.g. vendors, investigators) team members. For partnered trials this will preferably occur in a train the trainer mode.

· Ensure Partner is informed appropriately about any relevant Sponsor information that affects the management of the partnered trial.

· Ensure appropriate response to new safety information (e.g. update of trial documents) and ensure safety report distribution. For partnered trials oversee these duties performed by the Partner Project Manager.

· Participate in clinical summary document generation (e.g. INDs, NDAs) and other submission activities for study specific issues, results or analysis and description of individual cases.

· Contribute to process improvement initiatives and share best practice experiences with line managers and peers.

· Cooperate with and provide feedback to the UCB members of the partnering governance bodies as appropriate.

· Travel including overnight stays, required.

· May be asked to mentor colleagues;present the clinical trial internally or to an external audience;contribute to publications as appropriate;Perform other tasks as deemed necessary by the Company, e.g. duties described in the ACPM job description.

Job Profile:

Experience (List the type and length of experience) · At least three years’ relevant experience in clinical development including team leadership · Experience or capability to manage outsourced regional and/or local clinical studies from study start-up to study report completion

Specific skills (Include specific skills and knowledge necessary to meet the objectives of the position) · Clinical trial management and team leadership · Motivation, mentoring and integration of individuals on multi-functional international teams · Delivery of scientific/medical presentations and training to both large and small audiences · Excellent verbal and written communication in English · Proficiency in the Microsoft office suite · Good interpersonal skills · Excellent time management and organizational skills · Negotiation skills · Scientific and technical knowledge: - GCP and regulatory environment - Medical knowledge and research expertise - Basic principles of data management and statistics

Problem solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems) · Proactive approach, drive and follow through · Managing multiple concurrent responsibilities in an environment of changing priorities without close supervision · Ability to handle detailed technical matters and team dynamics · Reconciliation of conflicting priorities

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。
    
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为什么选择我们？

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。

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：chinacampus@ucb.com。应聘简历请在主题中注明申请职位名称。