Clinical Start-Up Specialist II — North America

ICON Strategic Solutions; México; Presencial; MXN 300.000 - 420.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global EAP LifeWorks

Life assurance

Flexible country-specific benefits

Descripción de la vacante

ICON Strategic Solutions is seeking a Study Start Up Associate II to support North America (US/CAN) trial activations. You will lead site start-up initiation, ensuring regulatory compliance and alignment with sponsor expectations.

You will coordinate across internal and external teams, prepare regulatory submissions, and maintain records while contributing to process improvements. Travel about 5% is expected.

Formación

• Bachelor’s degree in life sciences or related field.
• Minimum 2 years in clinical research or regulatory affairs with start‑up focus.
• Knowledge of ICH-GCP and local regulatory requirements.
• Strong organizational and project management skills; can manage multiple tasks.
• Excellent communication and ability to collaborate with cross-functional teams.
• Willingness to travel ~5%.

Responsabilidades

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

Conocimientos

Regulatory affairs

Study start-up

Project management

Communication

Cross-functional collaboration

Travel readiness

Educación

Bachelor's degree in life sciences

Descripción del empleo

ICON Strategic Solutions is seeking a Study Start Up Associate II to support North America (US/CAN) trial activations. You will lead site start-up initiation, ensuring regulatory compliance and alignment with sponsor expectations.

You will coordinate across internal and external teams, prepare regulatory submissions, and maintain records while contributing to process improvements. Travel about 5% is expected.