Regional Process Control Manager
- Shanghai, China
500+ On-going 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 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.
• Supports 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).
• Supports 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. Identifies monitoring risks through the analysis of audit and inspection findings, Quality indicators, process deviations and monitoring self-checks. Follows-up on and remediates quality signals through co-monitoring and/or Trial Monitoring process review in the region and collaboration with local managers/quality resources where issues are noted. 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.
• Supports local (and when needed global) audits & inspections working closely with Trial Monitoring country head and local managers, Regional Monitoring Excellence Head, and Global PCM Team. This includes support during preparation phase, during the inspections (and audits when needed) and after inspections and audits by supporting the development of the Corrective Actions and Preventive Actions (CAPA) and Follow-Up on CAPA.
• 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.
• Liaises with CHs, Regional Monitoring Excellence Head, Global PCM team, TMO Excellence regional and global Training Teams, and regional or country QA as applicable to identify quality gaps, set plan and act to address and ensure development of training in collaboration with TMO Excellence Training resources. Contributes to 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 (also from local audit and inspection learnings).
• Contributes to the development and implementation of new tools, processes and Operational Excellence initiatives from a regional Trial Monitoring perspective. Reviews local regulations only when needed, and contributes to the development of local SOPs. Provides day-to-day support to country Field Monitors in the areas of monitoring processes and procedures, and systems. Supports Trial Monitoring organization to ensure understanding and compliance of processes via guidance, instructions and share information on accessible platform. Supports process understanding during launch and implementation of new systems. Aligning with the organizational strategy and in collaboration with the Regional Monitoring Excellence Head and the Global PCM team and input from the region, develops global process and compliance strategy for Trial Monitoring.
What you'll bring to the role:
• University degree with significant life science experience. Advanced degree preferably in life sciences preferred.
• Fluent in both written and spoken English. Additional language, if used for local Business purposes.
• A minimum of 5 years of experience in Trial Monitoring, being 3 years in the field monitoring area. 1+ years in quality role preferred. Training experience desirable.
• Expert on ICH-GCP, international (i.e. FDA, EMA) and local clinical trials regulations.
• Excellent interpersonal, problem-solving, negotiation and conflict resolution skills. Excellent organizational skills, as well as predisposition to quality management and process improvement. Excellent communicator and presenter (oral and written)
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme.
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 inclusion workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
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 here: https://talentnetwork.novartis.com/network
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