-Oversees the execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements. Monitors adherence to protocols and determines study completion. Manages clinical and regulatory files and maintains clinical inventory intended for distribution to investigational sites. May interact with investigational sites, clinical consultants, Contract Research Organizations and other vendors. Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Major accountabilities:

•Oversees clinical program(s) across indications, executing medical strategy for development and marketed products in a defined therapeutic area.

•Is responsible for assuring aligned communication with Country/Cluster Clinical Research Associates, Managers and other key stakeholders on the execution and progress of the clinical studies.

•Identify new sites for clinical trials

analyze capability and make recommenda-tion for trial inclusion.

•Facilitate preparation and collection of site level documents

resolve problems as required.

•May execute site initiation and training.

•Implement total site management including monitoring visits, regulatory assess-ment, drug supply management and resolution of site problems to ensure compli-ance.

•Track trial execution milestones

identify problems

resolve issues and escalate as appropriate.

•May manage recruitment and execute contingency plans, as needed.

•Complete preparation/generation of study monitoring reports.

•May lead and chair local study team meetings, attend and participate in global clinical trial team meetings -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators:

•Deliver customer satisfaction results for internal and external customers -Delivery of Clinical Trials to quality standards and agreed timelines -Adherence to Novartis policy and guidelines and external regulations. Minimum Requirements:

Work Experience:

•Managing Crises.

•Functional Breadth.

•Collaborating across boundaries. Skills:

•Clinical Monitoring.

•Clinical Research.

•Clinical Trial Protocol.

•Clinical Trials.

•Decision Making Skills.

•Drug Development.

•Health Sciences.

•Lifesciences.

•Regulatory Compliance. Languages :

•English.

为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？

加入我们的诺华网络：这不是您心仪的职位？欢迎加入诺华人才社区，与我们保持联系，及时了解合适的职业机会。您也可以关注诺华集团招聘微信公众号及诺华集团招聘微信视频号。

薪酬与福利：您可以前往诺华官网了解我们帮助您实现个人与职业发展的举措。

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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Benefits and Rewards: Go to Novartis career website to learn about all the ways we’ll help you thrive personally and professionally.

Decision Making Skills

Regulatory Compliance

Clinical Research

Health Sciences

Clinical Monitoring

Drug Development

Clinical Trials

Lifesciences

Clinical Trial Protocol