摘要
~Supervisa la ejecución e interpretación de investigaciones de ensayos clínicos, actividades de recopilación de datos y operaciones clínicas. Establece y aprueba métodos científicos para el diseño e implementación de protocolos clínicos, sistemas de recopilación de datos e informes finales. Ayuda en investigaciones clínicas nuevas y constantes y en ensayos clínicos y asegura la eficiencia y el oportuno procesamiento de acuerdos de confidencialidad y acuerdos clínicos. Superv. el cumplim. de los protoc. y determ. la terminación de los estudios. Gestiona archivos clínicos y reglamentarios y mantiene el inventario clínico previsto para la distribución a sitios de investigación. Puede interactuar con sitios de investigación, consultores clínicos, Organizaciones de Investigación de Contratos y otros proveedores. Selecciona, desarrolla y evalúa personal para asegurar la operación eficiente de la función.
About the Role
Key Responsibilities
- Validate study designs and assess trial feasibility based on clinical practice and competitive analysis.
- Drive fast and high-quality trial site start-up through expert input during planning phases.
- Provide clinical expertise for IRB/EC interactions and informed consent content.
- Develop trial plans that address recruitment challenges and ensure data quality.
- Deliver robust training on indications, compounds, and protocols to internal and external stakeholders.
- Lead clinical recruitment strategies using physician insights and patient engagement.
- Support regulatory inspections and audits with scientific and clinical expertise.
- Ensure adherence to safety standards and provide medical input on adverse events.
Essential Requirements
- Advanced scientific degree (M.D. highly preferred; Ph.D. or Pharm.D. also considered).
- Strong understanding of clinical development processes and ICH/GCP guidelines.
- Minimum 3 years of experience in clinical development or clinical practice.
- Proven ability to lead cross-functional teams and resolve complex clinical issues.
- Excellent communication skills in English and the local language.
- Ability to deliver high-quality presentations and adapt across therapeutic areas.
Desirable Requirements
- Subspecialty training or experience with Real World Evidence (RWE).
- Familiarity with innovative study designs and data sources such as registries or electronic health records.
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
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Innovative Medicines
BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A
Research & Development
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