Global Study Manager

Icon Clinical Plc; Barcelona; Presencial; EUR 70.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive base salary

Health & wellbeing programs

Retirement and pension plans

Life assurance

Employee assistance

Learning and development

Descripción de la vacante

ICON busca un Global Study Manager para integrarse en el equipo de operaciones clínicas, gestionando estudios clínicos globales y asegurando entregas a tiempo y dentro del presupuesto.

Se requiere título en ciencias de la vida, 5+ años en investigación clínica y 3+ años en gestión de proyectos globales, con conocimiento de regulaciones ICH-GCP; experiencia en entornos matriciales y con IA/automatización. Puesto remoto a nivel internacional.

Formación

• Título universitario en ciencias de la vida o campo relacionado.
• Mínimo 5 años en investigación clínica, 3+ años en gestión de proyectos/globlal Study Manager dentro de farmacéutica o CRO.
• Conocimientos sólidos de regulación clínica (ICH-GCP).
• Capacidad para entregar proyectos a tiempo, dentro del presupuesto y con calidad.
• Experiencia trabajando con equipos internos y proveedores externos (configuración de proveedores, gestión y presupuestos).
• Excelentes habilidades de comunicación, trabajo en equipo y resolución de problemas.
• Capacidad de gestionar múltiples prioridades en un entorno matricial.
• Experiencia en todas las fases del ciclo de vida de los estudios clínicos.
• Experiencia en uso de IA/automatización en el trabajo diario de GSM.
• Conocimiento de GXP fuera de GCP (p. ej., GMP, GLP).
• Desirable: título avanzado (MSc, PhD).

Responsabilidades

• Apoyar la planificación, configuración, ejecución y cierre de estudios clínicos globales.
• Supervisar a proveedores y equipos por país para garantizar la entrega del estudio.
• Colaborar con equipos internos y socios externos.
• Desarrollar y actualizar documentos del estudio (protocolos, consentimientos).
• Gestionar proveedores externos, incluidos contratos y presupuestos.
• Asegurar el cumplimiento de regulaciones (ICH-GCP), SOPs y buenas prácticas.
• Contribuir a reuniones, auditorías e inspecciones.
• Apoyar la gestión de riesgos y la garantía de calidad.
• Mantener documentación del estudio y asegurar la preparación para inspecciones.

Conocimientos

Project management

ICH-GCP knowledge

Communication

Teamwork

Problem-solving

Multi-tasking

AI automation experience

Educación

Bachelor's degree in life sciences

MSc or PhD (desirable)

Herramientas

IRT systems

eClinical tools

Vendor management tools

Descripción del empleo

Descripción del trabajo

Global Study Manager ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As the world’s largest provider of Functional Service Provision (FSP), ICON Strategic Solutions embeds our teams within client organisations, serving as dedicated partners to some of the world’s leading pharmaceutical. By joining our FSP program, you’ll collaborate with an award-winning biopharmaceutical leader, renowned for innovation, inclusion, and making a real difference in patients’ lives. As a Global Study Manager (GSM), you’ll be fully integrated into the FSPs clinical operations team, helping to deliver innovative, global clinical studies. You’ll ensure projects are completed on time, within budget, and to the highest quality standards, working closely with both internal teams and external partners. This is a permanent and home-based role.

What you will be doing:

• Support the planning, setup, execution, and close-out of global clinical studies.
• Oversee vendors and country teams to ensure smooth study delivery.
• Work closely with internal teams and external partners.
• Help develop and update study documents (e.g., protocols, informed consent forms).
• Manage third-party vendors, including contracts and budgets.
• Ensure all study activities comply with regulations (ICH-GCP), SOPs, and best practices.
• Contribute to meetings, audits, and inspections.
• Support risk management and quality assurance efforts.
• Maintain accurate study documentation and ensure inspection readiness at all times.

Your profile:

• Bachelor’s degree (preferably in life sciences or related field).
• At least 5 years’ experience in clinical research, with 3+ years in Global clinical project management/ Global Study Manager within a Pharma or CRO.
• Strong knowledge of clinical research regulations (ICH-GCP).
• Proven ability to deliver projects on time, within budget, and to quality standards.
• Experience working with internal teams and external vendors including vendor set up, management and vendor budgets. (eg. central labs, IRT etc)
• Excellent communication, teamwork, and problem-solving skills.
• Ability to manage multiple priorities and work in a matrix environment.
• Experience in all phases of clinical study lifecycle.
• Experience in using AI automation in your daily work as a GSM.
• Knowledge of GXP outside of GCP (e.g., GMP, GLP).
• Desirable: Advanced degree (MSc, PhD).
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and our careers site.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know.

Locations: Spain, Barcelona; Hungary, Budapest; UK, Reading; Bulgaria, Sofia; Portugal, Lisbon; Greece, Athens; Czech Republic, Prague; Poland, Warsaw. Type: Full time.