Clinical Study Manager - Onco
诺华( 中国) 生物医学研究有限公司 China Novartis Institutes for BioMedical Research Co., Ltd.
- 公司性质:外资(非欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2021-01-01
- 工作地点:北京
- 招聘人数:若干人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:2-2.5万/月
- 职位类别:临床研究员 医药技术研发管理人员
职位描述
500+ Ongoing clinical trials;160+ Projects in clinical development; 80+ Major submissions planned 2020-2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.
Job Purpose:
The CSM is the single point of contact and local study team lead, within the Country/Cluster, for the assigned studies. The CSM is accountable to communicate with and support relationships with clinical investigators.
Your Key Responsibilities:
Your responsibilities include, but are not limited to:
- Trial Monitoring strategy: In collaboration with the Trial Monitoring key stakeholders (CSM Group Head, Regional Operations Manager (ROM), local/global medical, Trial Operations Manager (TOM), and global clinical assists in the development of local study execution plans and timeline commitments for a Country/Cluster.
- Allocation, initiation and conduct of trials: Supports study feasibility and country patient commitments in collaboration with Country/Cluster Trial Monitoring and Medical. Collects and manages input to the study protocol, and operational aspects of the study. Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track.
- Delivery of quality data and compliance to quality standards: Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
- Budget and productivity: Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study start up under the direction of their manager.
What you’ll bring to the role:
- A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable.
- Minimum 5 years’ experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
- Capable of leading in a matrix environment, without direct reports
- Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
Desirable requirements:
- Fluent in both written and spoken English, local language as needed in clusters/countries
- Demonstrated negotiation and conflict resolution skills both internal and external (site relationships;Communicates effectively in a local/global matrixed environment
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network.
职能类别:临床研究员医药技术研发管理人员
公司介绍
诺华(中国)生物医学研究有限公司是诺华全球研发组织――诺华生物医学研究所(NIBR)的第八个研究基地。我们位于中国上海市张江高科技园区,将成为诺华在亚洲的主要研究中心,以及除在欧美的研究中心外的最主要的研究中心。我们的研究和探索开发活动的重点是发现并开发创新疗法,用于治疗在亚洲远未达到医药需求的疾病。我们与从不同之处在于将专注现代药物的发现和开发方法的研究。最初阶段,研发工作将专注在引起中国地方性癌症的感染原因。我们还将开展临床试验,进行安全性研究,生物标志物和检测分析,表达谱、生物分析以及转化医学的研究。
随着公司业务的迅速扩展,我们热忱欢迎您的加入。同时我们将提供具有竞争力的薪酬福利待遇以及良好的培训发展机会。
联系方式
- 公司地址:地址:span上海市浦东新区张江高科技园区金科路4218号