南京招聘

Talent@Boehringer Ingelheim

About Corporate Functions

Corporate functions staff are the backbone of the company: talented, conscientious professionals who think outside the box and get things done. We set Boehringer Ingelheim's strategic compass to sustainable, reliable, innovative and customer-oriented. Internally, we ensure we have the employees' company needs covered so they can develop and grow here successfully. We also offer intelligent solutions and systems, overlook processes, investments and budgets, provide guidance to our businesses, and communicate to our internal and external stakeholders. We are proud of being a strategic partner to our business functions.

Job Responsibilities
-Full responsibility for the planning, conduct and reporting of clinical studies/trials (Phase II-IV) outsourced to a preferred provider CRO and covers the function of Trial Clinical Monitor (TCM,) where applicable to an outsourced task.

-Supervise and guide the CRO/vendors and by doing so, safeguard timelines, budget and quality of the clinical studies.

-Documentation of full oversight with the responsibility for safety of the study participants, continuous monitoring of the benefit-risk ratio of trial participation and the adherence to regulations, quality, and for data integrity.

-Maximize the value of the new Medical Device product for patients and BI.

-Trial preparation:
-Responsibility to define the scope as required to develop the Request for Proposal (RFP) to the Preferred Provider CRO in collaboration with the Sourcing Manager
-Manage/oversee/review all operational aspects of a clinical project/trial, such as planning/preparation, writing of core documents (e.g. CTP, CRF, CTR etc.)in close cooperation and with input from the project team, execution, reporting of trials and the overall management of the BI-CRO interface.
-Oversight/review all aspects of trial conduct in China, clinical trial supplies and logistics support
-Initiate vendors contracting
-Strong alignment with whole team involved in planning of data management.
-Facilitation of team decision making by providing clinical input.
-Foster and maintain close relationship with relevant regulatory authority for Software as a Medical Device and keep closely updated on all regulation changes.
-Plan and report trial budget
-Study conduct and reporting:
-Benefit-risk monitoring including regular medical and data quality review with the trial team and MST.
-Monitor compliance of trial sites and CRO team to GCP, local regulations and adherence to trial protocol through reports provided by the CRO, oversee corrective and preventive actions at the CRO level.
-Monitor compliance of the CRO team to GCP and oversee corrective and preventive actions
-Responsible for timely, complete and compliant archiving of all relevant documents for the TMF (both at the CRO and internally).
-Oversight to ensure timely cleaning and delivery of clinical trial data. Coordinate writing and review of the CTR.

-Monitor and supervise the progress of the project/trial/study, identifying bottlenecks, report progress to the Project Lead;

-Li

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。作为连续八年通过“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.    访问我们的官网,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
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