上海招聘

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.

Your key responsibilities:
Your responsibilities include, but are not limited to:
? Coordinates the implementation of process controls in TMO for assigned region with the
Regional Monitoring Excellence Head, the Global PCM team, CHs and other TMO
regional Process Control Managers to enhance the execution of monitoring procedures
in accordance with ICH-GCP, local regulations and Novartis standards.
? Drives continuous process improvement, harmonization, and simplification to increase
quality, speed and productivity in trial execution focusing on monitoring and field
monitor oversight. Works closely with other line function heads and Regional/Country
management to ensure excellent execution and delivery of clinical trial results. Based
upon findings of gap analyses, recommends changes to global, regional and country
management.
? Drives implementation of the local self-check actions (e.g., local Process Control Plan,
KPIs) with appropriate area of focus, targeted and timely mitigation plans and actions
(local/regional trainings).
? Responsible for communication to TMO RH and CHs to assure high quality performance
and coordination of TMO actions derived from audits, inspections, Quality KPIs and
other metrics.
? Implements issue identification and root cause analysis to troubleshoot systemic issues
in countries and help them resolve through new or enhanced processes, guidances,
innovations (systems, tools), or training.
? Ensures inspection readiness through the coordination of preparation activities for the
region (as needed by countries and in collaboration with local QA and the other roles in
Monitoring Excellence) and risk assessments to reduce significantly the chance of a
critical issues related to trial monitoring to exist in submissions.
? Performs signal detection through the critical analysis of data from metrics, Quality
KPIs, quality trends identified in TMF, MVR issues, Risk Management Systems, audits
and inspections, root cause analyses from tools including: clinical trial management
systems, trial databases, metrics, TMF, Quality KPIs and other risk management systems
to target needs in an ongoing manner and putting in place actions to explore those
signals and correct or remediate to improve the quality and effectiveness of monitoring.
? Manages the flow of routine communications, reporting to the region and countries on
quality performance. Ensures lessons learned and best practice sharing within the
region with regards to TMO quality and process improvement topics.

What you’ll bring to the role:
? University degree with significant life science experience
? Fluent in both written and spoken English. Additional language, if used for local Business purposes.
? A minimum of 7 years of experience in Trial Monitoring, being 5 years in the field monitoring area. 2+ years in quality role preferred. Training experience desirable.
? Expert on ICH-GCP, international (i.e. FDA, EMA)
? Excellent interpersonal, problem-solving, negotiation and conflict resolution skills and local clinical trials regulations.

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.

微信分享