Study Start-Up Specialist II: Regulatory & Site Activation

ICON Clinical Research; Madrid; Presencial; EUR 42.000 - 65.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Retirement planning

Life insurance

Employee assistance programme

Descripción de la vacante

ICON plc is a world-leading healthcare intelligence and clinical research organization, inviting you to join its mission to shape the future of clinical development from our Madrid office. As a Study Start Up Associate II, you will drive site initiation activities, ensuring regulatory compliance and efficient start-up of trials, while collaborating with global teams to deliver on time and quality.

You will lead regulatory document preparation, submissions, and stakeholder coordination, and you

Formación

• Bachelor's degree in life sciences or a related field.
• Minimum of 2 years of experience in clinical research or regulatory affairs, with study start-up experience.
• Strong understanding of regulatory requirements including ICH-GCP and local regulations.
• Excellent organizational and project management skills with ability to manage multiple tasks.
• Excellent communication and interpersonal skills with cross-functional collaboration.
• Willingness to travel approx. 5%.

Responsabilidades

• Lead preparation and submission of regulatory documents (CTA, ethics committee submissions, regulatory communications).
• Coordinate with internal and external stakeholders to obtain approvals for study initiation.
• Maintain comprehensive records of regulatory submissions, approvals and correspondence.
• Provide guidance on regulatory requirements and best practices for study start-up.
• Participate in process improvements to streamline start-up processes.

Conocimientos

Regulatory knowledge

Project management

Cross-functional collaboration

ICH-GCP familiarity

Travel readiness

Educación

Bachelor's degree in life sciences or related field

Descripción del empleo

ICON plc is a world-leading healthcare intelligence and clinical research organization, inviting you to join its mission to shape the future of clinical development from our Madrid office. As a Study Start Up Associate II, you will drive site initiation activities, ensuring regulatory compliance and efficient start-up of trials, while collaborating with global teams to deliver on time and quality.

You will lead regulatory document preparation, submissions, and stakeholder coordination, and you