REQ-10060641
8月 21, 2025
China

摘要

~ 从临床试验执行的角度监督战略和运营规划/管理。监督指定试验中的预算和资源分配。通过流程改进和项目/特许经营内试验之间的知识共享,实现卓越运营。 使有能力的组织能够在矩阵环境中导航并快速适应业务需求。

About the Role

Key responsibilities:

  • 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/extended country group level by ensuring:
    • Site identification and selection, trial feasibility evaluation
    • 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)
    • Manages the study specific feasibility questionnaire and sends to all participating sites together with any supporting documentation, if applicable
    • Follows up with sites to ensure questionnaires are answered and any additional feedback is obtained
    • 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
    • Enters feedback into global database if applicable (e.g. CLIP).
  • Collects, analyses, and interprets data to provide comprehensive proposals and timelines for country / extended country group 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/extended country group 
  • 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.
     

Essential requirements:

  • Scientific degree and advanced degree with clinical trial experience and/or project management, is preferable
  • Fluent in both written and spoken English
  • 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
  • Strong project management capabilities

Desirable requirements:

  • Agility to move fast across different therapeutic areas and indications
  • Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial
  • Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care
  • 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 (site relationships)
  • 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? http://www.novartis.com/about/strategy/people-and-culture

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REQ-10060641

Global Clinical Operations - Feasibility Manager

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