Clinical Research Associate Iii
hace 4 semanas
Descripción de Puesto
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis
Responsabilidades ClaveSu responsabilidad incluye, pero no se limita a:
- El Clinical Research Associate realiza actividades de supervisión relacionadas con la iniciación, conducción (reclutamiento, recolección de datos de calidad) y finalización oportuna en diferentes Fases y para diferentes Áreas Terapéuticas para ensayos clínicos de Oncología y Pharma dentro del país;
- El CRA es responsable de entregar datos dentro de los plazos y estándares de calidad requeridos, responsable de la adherencia a los procedimientos de monitoreo de acuerdo con las regulaciones internas y locales;
- Asignar, iniciar y conducir ensayos, realizar selección de sitios y recomendar sitios potenciales para evaluar su capacidad para llevar a cabo un ensayo clínico, realizar el cierre de sitios y asegurar una colaboración exitosa entre los sitios y Novartis para cumplir con las expectativas sobre hitos y entregas;
- Identificar problemas en los sitios; resolver problemas y elevar según corresponda y colaborar con socios internos;
- Realizar capacitación continua para enmiendas y nuevo personal del sitio y llevar a cabo actividades de monitoreo continuo (en el sitio y remoto) para asegurar el cumplimiento del protocolo, GCP, regulaciones y procesos globales y locales para asegurar la integridad de los datos y la seguridad del paciente;
- Documentar las actividades de supervisión con precisión siguiendo los estándares de Novartis; Colaborar con el Jefe del Grupo de Asistentes de Investigación Clínica/Gerente de Estudio Clínico para asegurar planes de reclutamiento y ejecutar planes de contingencia, según sea necesario; Realizar tareas adicionales según se asignen;
- Participar en actividades de organización de auditorías y preparación para inspecciones para actividades de monitoreo y sitios según sea necesario y asegurar la implementación de acciones correctivas dentro de los plazos especificados.
Novartis se compromete a crear un entorno de trabajo excelente e inclusivo y un equipo diverso que represente a los pacientes y las comunidades a las que servimos.
Requisitos MínimosLo que traerás al rol:
- Tiene un título en Ciencias de la Vida, Medicina, Salud o equivalente adecuado;
- Habilidades sofisticadas en español e inglés (escrito, lectura y conversación);
- 2 años de experiencia validada en desarrollo farmacéutico, investigación clínica y/o supervisión de ensayos clínicos, comprensión de los aspectos internacionales del proceso de desarrollo de medicamentos para diferentes Áreas Terapéuticas y Fases;
- Capacidad para trabajar con diferentes ensayos al mismo tiempo; gestión de presupuesto y tratamiento;
- Experiencia en identificar nuevos institutos de salud o CROs y trabajar con los actuales;
- Construir relaciones sólidas y acuerdos con ellos;
- Preferentemente haber trabajado antes en compañías farmacéuticas o con proyectos farmacéuticos;
- Conocimiento de ICH-GCP, regulaciones de ensayos clínicos internacionales (es decir, FDA, EMA) y locales;
- Disposición para viajar;
- Excelentes habilidades para comunicarse, influir, persuadir y negociar con diferentes equipos y socios;
- Altos niveles de ética e integridad;
- Siempre busca la Excelencia Operativa;
- Capacidad para buscar problemas y cuestiones complejas;
- Excelentes habilidades de trabajo en equipo.
Global Drug Development
Unidad de NegocioGDO GDD
PaísArgentina
Ubicación oficinasCapital Federal
Empresa/Entidad LegalNovartis Argentina S.A
Área FuncionalInvestigación y desarrollo
Tipo de PuestoTiempo completo
Tipo EmpleoFijo
Trabajo por TurnosNo
Talento Temprano (0-4 años de experiencia)Si
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