宁波招聘

职位描述：
Description:
The CML is responsible for the planning, conduct, completion and reporting of clinical trials under supporting and supervision on a local OPU level according to all applicable regulations and general quality requirements.

Duties & Responsibilities:
1. Resource management
? To be involved in evaluation of CRA resource for assigned trial,
? Prepare investigator and site profile and decide on site selection by supervision,
? Responsible for IMP import, distribution, return and destruction per local regulation and BI requirement under oversight,
? Ensure all required local study documents including the patient information and informed consent documents in local language as well as local protocol amendments and all documents in the ISF, in close cooperation and with input from the TCM, CRA team and all other involved functions,
? Responsible for translation and reviews of trial medication labels in cooperation with local DRA or other internal review functions,
? In charge of clinical trial related equipment imported or purchased in China OPU, and relevant distribution, return,
? Work with CRO manager/Purchasing on CRO/Vendor selection and provide feedback on service received.
2. Trial oversight, management and operational activities
? Ensure timely study milestone delivery,
? Responsible for preparation of the enrolment plan with support if needed,
? Responsible for routine tracking of the enrolment plan vs actual enrolment,
? Ensure timely cleaning and delivery of trial data and documents, supports the completion of the Clinical Trial Report (provision of appendices) with support if needed,
? Update systems timely and ensure the completeness and accuracy, e.g. CTMS,
? Ensure patient safety during the conduct of the trial by reviewing regional/local safety information.
3. Budget management
? Understand BI Cost structures, especially the trail budget; Clearly distinguish the cost allocation between BI & Vendors,
? Establish and monitor local budget aspects including investigator fee with support if needed,
? Prepare budget specification and offer for assigned study,
? Responsible for IMC review through closing working with medical controller; Familiar with Finance budgeting cycle and take actions according to the timeline,
? Periodically tracking and control the actual spending and extra budget based on the most updated milestone; Ensure study budget is well tracked and controlled within defined deviation percentage.
? Understand updated Finance SOPs and the impacts on daily business.
4. Quality management
? Meet mandatory compliance requirements and standards including ICH-GCP, BI SOP/guideline and regulatory requirement,
? Coordinate to ensure appropriate study specific and medical/scientific training and advice delivered to local team including CRAs, CRO and site staff,
? Act as CAPA leader for Trial case,
? Ensure appropriate escalation of issues related to trial conduct and procedures as well as adequate support of CAPA,
? Develop Risk Management Plan under guidance from line manager & timely maintenance during the whole trial process,
? Conduct co-monitoring per BI SOP/Guideline request,
? Closely monitoring the clinical data including patient safety data to be reported timely, correctly.
5. Provide leadership
? Provide leadership in the oversight and management of investigational sites in partnership with other key stakeholders (e.g. CRAs), including correct handling of IMP, patient data and material (e.g., biological samples) with support if needed,
? Lead local team including CRO for outsourced study or CRA/CTA to manage the trial in accordance to protocol, SOP, ICH-GCP and regulatory requirement through routine meeting and timely communication including e-mail, phone call and newsletters by supervision,
? Close contact with the global trial team and support of global trial activities,
? To participate in communication with cross function including DRA team, CDMA team, PV team and BDM team, etc.


Requirements:
? Bachelor or above in medical, nursing, pharmaceutical or other bio-science related area.
? Structured mind-set, good scientific, medical and analytical thinking,
? Basic medical knowledge of the disease under investigation, trial related risks, and understanding of the Investigational Medicinal Product, procedures and study design and their potential impact on patient's wellbeing,
? Good knowledge of the Clinical Development process, including the regulatory requirements is preferred,
? Proficiency in all common office software and smooth self-training of new software programmes (user),
? Ability and willingness to travel domestic and overseas and to use electronic means of communication.

Eligibility Requirements:
　
Our Culture:
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
 
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.
 
In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.
 
For more information please visit www.boehringer-ingelheim.com 举报 分享

关于勃林格殷格翰
加入勃林格殷格翰，与我们一起携手并肩，共创未来。我们深信每一位员工的成长都将铸就公司的发展，每一位员工的努力也都将成就公司的美好明天。130余年来，研发驱动型制药公司勃林格殷格翰作为全球前20大制药企业之一，持续致力于人用药品、动物保健和生物制药合同生产三大业务领域，力争为人类和动物带来更多健康。加入勃林格殷格翰，将是您实现“创新展现价值”的绝佳机会！在工作中，您将通过与内外部伙伴的通力合作，站在知识迭代的最前沿；科研过程中，您将不断探索新型科学发现，切实提高全人类的生活质量；与此同时，您也将助力公司成为未来行业当之无愧的领导者。

我们的业务正处在持续高速发展之中，是中国业内发展最快的公司之一。我们诚邀您加入勃林格殷格翰，共同携手向前，成为实现2025愿景的一份子。

作为业内的领导企业，热情、创新和独立是驱动我们不懈前行的动力，我们为每一位努力热忱、恪尽职守的员工提供成长机会，实现其个人价值。作为连续七年通过“中国杰出雇主”认证的企业，我们通过提供高质量的职业发展规划、参与或领导国际项目的机会，为每一位员工的成功之路夯实基础。
 让我们彼此成就，引领未来！

想获取更多信息，有以下方式：
1.    访问************************************/或
2.    关注我们领英账号, 或
3.    关注我们的微信公众号：BI招聘

行为准则
-责任心：即使情况不明朗，我们总是在自己的决策和行为中展现主人翁精神
-敏锐度：面对内外部变化时，我们以开放的心态快速应对
-内部企业家精神：我们与客户携手构筑创新理念，以应对瞬息万变的市场

联系我们
如果你坚信自己就是我们要找的人，不要犹豫，马上申请吧!