349123BR
Aug 02, 2022
China

Job Description

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:
Strategy development
• Collaborate with Region leadership team to identify innovative practices to optimize country operations, including resource optimization, accelerated study start-up and use of big data to achieve performance and business impact
• Seeks and evaluates external knowledge and best practices for potential application to enhance overall operational excellence of country trial operations

Execution and Quality
• Collaborates with cross functions to ensure Study Start-up team (contracts, budgets, EC approval) timelines are delivered and reported per established country commitments
• Accountable for drug supply management in coordination with country/regional depot processes
• Implements innovative and efficient processes which are in line with Novartis strategy
• Ensures adherence to financial standards, prevailing legislation, GCP, Ethical Committee, Health Authority Submission and SOP requirements
• Assures that Study Start-up (IRB, HA, RIS, Site Initiation) milestones are met

People & Resource management
• Responsible for the hiring, training, development and retention within the team including Study Start-up, Contract & Finance, HRG management, IMP management.
• Responsible for resource management and reporting within Trial Activation Team, including the assessment and allocation of resources to ensure a balanced workload across all functions
• Ensures associates have the required level of skills to successfully execute studies with high quality and according to business objectives
• Responsible for managing and addressing TMO performance targets per defined objectives, and serves as an escalation point for Trial Activation Team

Productivity & Budget
• Ensures appropriate budget controls are in place to achieve TMO business objectives
• Responsible for performance reporting (KPIs) through available systems and is the escalation point for administrative and other business relevant systems issues to assure proper functioning and quality
• Participates in country productivity initiatives to improve operations, including optimizing resource synergies

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• University degree in medicine or natural sciences. Fluent in both written and spoken English
• At least 10 years experience in clinical research operations and planning
• At least 5 years experience in people management and team leadership
• Excellent understanding of all aspects of clinical drug development with particular emphasis on trial execution and monitoring
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards
• Strong capability in working in a global/country matrix environment
• Proven successful leadership of teams, preferably with experience in working with international teams
• Proven strong leadership skills, strategic thinking and matrix management skills

Desirable Requirements:
• Strong interpersonal, negotiation and conflict resolution skills
• Strong communicator and presenter (oral and written), ability to communicate to Sr. Management
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 here: https://talentnetwork.novartis.com/network
Global Drug Development
GDO GDD
China
Shanghai
Research & Development
Full Time
Regular
No
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349123BR

Head Trial Activation

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