Job Description
Summary ~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: - Provide clinical development and indication expertise specific to the country/cluster.
- Validate study designs, contribute to the start-up phase, provide robust training to clinical operations teams and support recruitment and trial awareness.
- Offer clinical/medical expertise for IRB/EC interactions and informed consent forms.
- Interact with external experts, regulatory authorities, and patient advocacy groups.
- Leverage innovation in clinical trial planning and recruitment strategies.
- Support internal stakeholders and decision boards regarding clinical trials.
- Review and resolve trial-related scientific/clinical/medical issues and support protocol deviations.
Essential Requirements - Scientific degree M.D., Ph.D., or Pharm.D. (M.D. highly desirable) - Subspecialty training desirable
- 3 years of clinical development experience in the pharmaceutical industry or clinical practice.
- Ability to manage a study from the scientific/medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex scientific/clinical/medical/operational issues.
- Ability to lead effectively by communicating well, motivating a cross-functional team, and handling and delegating responsibilities.
- Agility to move quickly across different therapeutic areas and indications.
- Demonstrated problem-solving skills and comfort with complexity.
- Ability to prepare and deliver high quality presentations.
- Speaks and writes English and French
Desirable Requirements - Sound understanding of the overall clinical development process, and ICH/GCP principles.
At
Novartis Canada , we are determined to be a valued partner and advocate, with a deep understanding of patient needs along the entire care journey – from drug development, to diagnosis, to access and beyond. Part of the way we are doing this is by leveraging data, technology, and partnerships.
Research & Development : we focus on four core therapeutic areas: Cardiovascular, Renal & Metabolic, Immunology, Neuroscience and Oncology. We also develop and deliver treatments through other promoted and established brands, which today are helping millions of patients. Over the last three years, our average annual research and development investment in Canada was over $30 million, and we conduct clinical trial research in every region throughout Canada.
Commitment to Diversity and Inclusion : Novartis is committed to building outstanding, inclusive work environment and diverse team’s representatives of the patients and communities we serve.
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?
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