大庆招聘

  

• Administrative support to Clinical Project Managers (e.g. managing facilities, logistics of meetings, document management and archiving, meeting minutes, maintenance of local processes/online systems related to compliance and purchasing/payment, support for the reconciliation of activities
• Coordinate the stamping process for the study relevant activities/documents
• Develop TMF Plan, conduct ongoing and final QC checks of TMF for sections owned by GCPM; providing CRO or Partner with queries/feedback to ensure correctness and completeness of documents and of TMF overall.
• Provide support to COL/CPM for setting-up studies in the UCB Clinical Trial Management System (CTMS), provide information to CTMS team to ensure data fields owned by UCB are kept up to date. Conduct ongoing and final QC checks of the UCB CTMS, liaise with Partners/CPM to provide feedback and ensure resolution of issues.
• Liaise between Partners, CPM, Study Physician, QA and Legal on local Informed Consent questions and ensure fast resolution.
• Check UCB Data Standard COA Repository and liaise with CPM and OC to identify vendors and obtain licensing agreements.
• Responsible to manage the Letter of Authorization/Delegation of Authority/Power of Attorney process and obtain LOA/DOA/POA signatures for GCPM.
• Manage Activity Notification Form (ANF) process and reconciliation for study specific activities that is out of scope for the Partner (e.g. Data Review Boards, KOL interaction).
• Request the set-up of study mailboxes for all studies and ensure access management.
• Request and review the aggregate financial reports for studies managed by GCPM from UCB Compliance and highlight any significant payments to COLs and CPMs. Assist COLs and CPMS with documenting due diligence to mitigate potential bias.
• Perform spot checks on Site Regulatory Packages (SRP), Form FDA1572s and PI CVs as necessary.
• Drive the implementation of new technologies/systems in clinical trials managed by GCPM.
• Act as subject matter expert on UCB systems and continue to find efficiencies between UCB systems and Partner systems (e.g. IMPACT, TMF, Mikado, U Pilot, SharePoint).
• In collaboration with CPM, support audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner.
• Participate in Clinical Study Team meetings and/or other trial-related meetings when their specific expertise is required.
• Contribute to process improvement initiatives and share best practice experience with Line Manager and/or CPM as appropriate.
• Occasional travel including overnight stays may be required.
• Perform other tasks as deemed necessary by the Company.

  

  

Required qualifications

  

• Good verbal and written English and local language skills

• Excellent communication skills and attention to detail

• Highly proficient in MS Office Suite

• Ability to rapidly learn new tasks and skills

• Strong organizational and time management skills

• Preferred scientific and technical skills

• Knowledge of GCP and ICH Guidelines, FDA and/or EU regulations

• Positive attitude towards Change Management

• Basic knowledge of medical terminology

• Ability to work on multiple concurrent assignments

• Ability to work independently and manage own workload

• Ability to work in an international team environment

• Ability to be creative and flexible and function in a fast paced environment

• Ability to proactively analyze and challenge processes and propose solutions

• Able to liaise and discuss with internal and external stakeholders

• Able to identify and create efficiencies to support the delivery of UCB portfolio

• Ability to learn and master new technologies and systems and train colleagues on technologies and systems

Remark: The contract would be 2 year contractor with CIIC.

                                  

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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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。

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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。