347491BR
Jun 22, 2022
China

Job Description

5600 people dedicated to discovery! 6 research locations around the globe. The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis. We collaborate across scientific and organizational boundaries, with a focus on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. the lives of millions.

Your key responsibilities:
Your responsibilities include, but are not limited to:
· Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality /compliance and performance standards.
· Conduct study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
· May identify new sites for clinical trials; analyze capability & make recommendation for trial inclusion.
· 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 education, implementation & compliance to standards (SOPs) & best practices for clinical operations within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
· Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
· Support study activities in China, including feasibility, CTA and HGRAC submission, site start up, maintenance and close out.

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:
· Advanced degree or equivalent education/degree in life science/healthcare strongly recommended
· ≥ 4 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
· Good knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
· Basic knowledge of oncology and/or hematology, or experience in early clinical development preferred.
· Hands-on experience in data cleaning and analysis recommended.
· Good communication, writing and organization and skills

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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347491BR

Clinical Trial Leader I

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