343559BR
Apr 11, 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:
·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.
·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.)
·Managing interactions with relevant line functions including data management, drug supply management, clinical development and Novartis Country Pharma Organizations; 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)

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
· Operations Management and Execution
· Project Management
· Cross Cultural Experience
· English
· Advanced degree or equivalent education/degree in life science/healthcare strongly encouraged.
· At least 1 year scientific, strategic and operational experience in planning, executing, reporting and publishing clinical studies in industry or academia, or at least 3 years in Clinical Operations/Clinical Scientific role

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis network: If this role is not suitable to your experience or career goals but
you wish to stay connected to hear more about Novartis and our career opportunities, follow us via Novartis Group WeChat Recruitment Account.

NIBR
TCO NIBR
China
Shanghai
Research & Development
Full Time
Regular
No
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343559BR

Associate Clinical Trial Leader

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