Study Start-Up Specialist: Drive Trial Startups

ICON; Madrid; Presencial; EUR 42.000 - 64.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave

Health insurance

Pension plan

Global EAP LifeWorks

Life assurance

Descripción de la vacante

ICON plc, a world-leading healthcare intelligence and clinical research organization, seeks a Study Start Up Associate II in Spain. You will lead site start-up activities, ensure regulatory compliance, and collaborate across teams to progress clinical trials.

Requirements include a life sciences degree and at least 2 years in clinical research or regulatory affairs, with strong regulatory knowledge and travel willingness.

Formación

• Bachelor's degree in life sciences or related field.
• Minimum of 2 years in clinical research or regulatory affairs with study start-up experience.
• Strong understanding of regulatory requirements and ICH-GCP guidelines.

Responsabilidades

• Lead site start-up and activation activities and manage deliverables.
• Prepare and submit regulatory documents (CTA, ethics submissions, regulator communications).
• Coordinate with internal/external stakeholders to obtain approvals for study initiation.
• Maintain accurate records of regulatory submissions, approvals and correspondence.
• Provide guidance on regulatory requirements and drive process improvements for start-up activities.

Conocimientos

Organizational skills

Communication

Cross-functional collaboration

Regulatory awareness

Educación

Bachelor's degree in life sciences

Descripción del empleo

ICON plc, a world-leading healthcare intelligence and clinical research organization, seeks a Study Start Up Associate II in Spain. You will lead site start-up activities, ensure regulatory compliance, and collaborate across teams to progress clinical trials.

Requirements include a life sciences degree and at least 2 years in clinical research or regulatory affairs, with strong regulatory knowledge and travel willingness.