343018BR
May 17, 2022
Japan

Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

Job Purpose:
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 operational excellence through process improvement and knowledge sharing.

-Contributes to all operational/clinical trial deliverables that are in scope of the specific JD, according to timelines, budget, operational procedures, quality /compliance and performance standards. -Conduct/Contribute to study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
-May/may not be involved in identifying new sites for clinical trials; analyze capability and make recommendation for trial inclusion.
-Ensuring proper handling of all study conduct and close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation (if in scope of the specific JD).
-Responsible for education, implementation and compliance to standards (SOPs) and best practices for clinical operations/clinical data review activities 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
-Distribution of marketing samples (where applicable)

Why consider Novartis?
 
817million. That’s how many lives our products touch. 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.
 
We are Novartis. Join us and help us reimagine medicine.
 
ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。
約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。
ノバルティスファーマ株式会社は、スイス・バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp

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

Operations Management and Execution Project Management Financial Management Collaborating across boundaries English Trial Planning and Feasibility Clinical Trial Set-up, Management & Conduct Regulatory Strategy

NIBR
Translational Medicine
Japan
Tokyo
Research & Development
Full Time
Regular
No
careers default image
343018BR

Clinical Scientist

Apply to Job Access Job Account