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The SSO Study Start-Up Team Lead is accountable for the governance and oversight of a study start-up team in a standalone country or OPC (operating country). The SSO Study Start-Up Team Lead is supporting the country/OPC SSU strategy and prioritization in close collaboration with SSU/OPC Head and Country/OPC LT to deliver operational excellence of the GDD portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.

About the Role

Key responsibilities:

Study Start-Up Strategy

Supports Study & Site Operations Country Leadership Team to identify innovative practices to optimize country operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impact
Seeks and evaluates external knowledge and best practices to enhance overall operational excellence of country trial operations
Supports country SSU strategy in close collaboration with SSU/OPC Head and Portfolio Head/Portfolio Team Lead(s)
Responsible for timely start-up activities from country allocation until site Green Light (ready-to-initiate-sites)
Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable

Allocation, initiation and conduct of trials

Collaborates with Head Portfolio, SSO Portfolio Team Leads and global study team (Clinical Operations Program Head, Trial Lead) to ensure SSU timelines and deliverables are met according to country commitments
Accountable for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness
Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
Implements innovative and efficient processes which are in line with Novartis strategy

People and resource management

Hiring, training, development, and retention of Study Start-Up associates
Resource management and reporting of Study Start-Up associates
Ensures associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectives
Manages and oversees productivity targets per defined objectives, and serves as an escalation point for Study Start-Up functions

Essential requirements:

A degree in scientific or health discipline required
Fluent in both written and spoken English
Fluent in both written and spoken country language
Minimum 5 years’ experience in clinical operations and planning
Proven leadership capabilities and experience (with or without direct line management responsibilities).
Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/national Health Authorities regulations and Novartis standards
Strong capability in working in a global/country matrix environment

Desirable requirements:

Proven successful leadership of teams (with or without direct reports), preferably with experience in working with international teams
Strong interpersonal, negotiation and conflict resolution skills Communicates effectively in a local/global matrixed environment

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: Learn about all the ways we’ll help you thrive personally and professionally.
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Division

Development

Business Unit

Development

Location

China

Site

Beijing (Beijing)

Company / Legal Entity

CN14 (FCRS = CN014) China Novartis Institutes for BioMedical Research Co., Ltd.

Alternative Location 1

Shanghai (Shanghai), China

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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