About the Role

Major Accountabilities

• Single point of contact for communication between Clinical Operations Program Managers / Clinical Operations Program Head, country/extended country group Study & Site teams and local relevant medical/clinical functions for all requests for program/study feasibility
• Coordinates the feasibility activities on country by ensuring:
  o Site identification and selection, trial feasibility evaluation
  o Collates/validates the list of potential sites by utilizing internal and external data (e.g. historical data, individual knowledge within local Study & Site Team and relevant medical/clinical functions, internal and external databases)
  o Manages the study specific feasibility questionnaire and sends to all participating sites together with any supporting documentation, if applicable
  o Follows up with sites to ensure questionnaires are answered and any additional feedback is obtained
  o Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed-back, etc.) and analysis of the competitive environment
  o Enters feedback into global database if applicable (e.g. CLIP).
• Collects, analyses, and interprets data to provide comprehensive proposals and timelines for country allocation of clinical programs and assigned trials
• Responsible for early identification for potential risks and opportunities as well as potential synergies and back-up strategies within the country
• Closely collaborates with the Study & Site team to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development
  clinical trials with the Study & Site Operations

Key Performance Indicators

• Timely submission of feasibility data
• Performance against study commitments at the country level, including delivery of studies per defined number of patients and quality
• Delivery of study milestones esp. in startup phase in adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements

Work Experience

• Scientific degree and advanced degree with clinical trial experience and/or project management, is preferable
• Minimum 5 years' experience clinical development experience in pharmaceutical industry
• Capable of leading in a matrix environment, without direct reports and working cross-border
• Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex-clinical / medical / operational issues
• Agility to move fast across different therapeutic areas and indications

Skills

• Strong project management capabilities
• Ability to assess the feasibility of implementing the protocol based on regional medical practice and sound understanding of the overall clinical development plan
• Demonstrated negotiation and conflict resolution skills both internal and external
• Communicates effectively in a local/global matrixed environment

Language

• Fluent in both written and spoken English

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: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

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 diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.

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

Japan

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 midcareer.japan@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

ノバルティスは障害を持つ個人と協力し、合理的配慮を提供することをお約束します。

健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の必須事項を果たすために合理的配慮が必要な場合は midcareer-r.japan@novartis.com宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Development

Business Unit
Innovative Medicines

Location
Japan

Site
Head Office (Japan) (Pharmaceuticals)

Company / Legal Entity
JP05 (FCRS = JP005) Novartis Pharma K.K.

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No