Summary
-Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team.
About the Role
Major accountabilities:
- Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality /compliance and performance standards.
- Development of specific sections of the protocol and related documents; -Development of study tools, guidelines and training materials; -Implementing issue resolution plans; -Acting as point of contact for all site-related issues and procedural questions; -Assist with program level activities (e.g., tracking of program-related publications, development of clinical sections of regulatory documents etc.) -Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
- Responsible for implementation of best practices and standards including sharing lessons learned.
- Frequent internal company and external contacts.
- May represent organization on specific projects -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Want more jobs like this?
Get jobs in Shanghai, China delivered to your inbox every week.
Essential Requirements:
- Cross Cultural Experience.
- Project Management.
- Operations Management and Execution.
- Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials.
- Data Management, Detail Oriented, Health Sciences.
- Lifesciences, Negotiation Skills.
- Project Management, Project Planning.
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? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Biomedical Research
Business Unit
Pharma Research
Location
China
Site
Shanghai (Shanghai)
Company / Legal Entity
CN14 (FCRS = CN014) China Novartis Institutes for BioMedical Research Co., Ltd.
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No