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      Study Leader

      REQ-10051739
      5月 19, 2025
      Ireland

      摘要

      The Study Leader co-leads together with the Clinical Science Lead (CSL) the cross-functional clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT) and GCO objectives.
      Contributes in promoting operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs.

      About the Role

      Key responsibilities:
       

      • Co-leads clinical trials, promotes operational excellence with agile principles, and ensures on-time delivery of studies.
      • Fosters an agile culture within assigned studies to maximize collaboration and achieve long-term business impact.
      • Collaborates with regulatory writing and clinical development to develop global clinical trial protocols and study-related documents.
      • Maintains up-to-date study status, risks, and issues, and ensures readiness for inspections and audits.
      • Oversees study recruitment and works closely with SSO Clinical Program Managers and Vendor Partnerships & Governance to deliver clinical study objectives.
      • Ensures proper handling of all study close-out activities such as site close-outs and final drug accountability.
      • Contributes to the development of clinical study reports, and partners with Portfolio Strategy & Planning to align studies with program strategy.
      • Builds high-performing teams, fosters psychological safety, and serves as the single point of contact for internal/external customers.

      Essential requirements:

      • Bachelor's degree in life sciences or healthcare, with an advanced degree preferred.
      • Minimum 2 years’ experience in clinical research or drug development in academic or industry environments, spanning Phases I to IV.
      • At least 1 year experience conducting global clinical studies including planning, execution, and reporting, in compliance with international standards like GCP/ICH and health authorities' regulations.
      • Experience managing teams in a complex, matrix, and global environment, preferably virtual teams.
      • Demonstrated ability in building effective relationships with internal and external stakeholders.
      • Strong communication and presentation skills, both oral and written.
      • Proven organization and prioritization abilities, along with negotiation, conflict resolution, and an enterprise mindset.
      • Strong project management skills, strategic thinking, and problem-solving abilities; knowledge of relevant therapeutic area is preferred.

      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

      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: http://talentnetwork.novartis.com/network

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

      Development
      Innovative Medicines
      Ireland
      Dublin (NOCC)
      Research & Development
      Full time
      Regular
      No

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

      A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
      REQ-10051739

      Study Leader

      Apply to Job

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