**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 productivo 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.
Division
Development
Business Unit
Innovative Medicines
Location
Mexico
Site
INSURGENTES
Company / Legal Entity
MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
**Ajustes de accesibilidad**:

📌 Clinical Research Medical Advisor (Baja California Sur)
🏢 Novartis
📍 Baja California Sur