Clinical trial applications and ethics submissions
Coordination with internal and external stakeholders
As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies
Job Summary
As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.
ICON offers a diverse culture that rewards high performance and nurtures talent, with benefits focused on well-being and work-life balance for employees and their families.
ICON is committed to providing an inclusive and accessible environment, ensuring equal consideration for employment without discrimination and offering reasonable accommodations for candidates with disabilities.
Matching Summary
As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.
Skills & Requirements
Must-have
Regulatory document preparation and submission
Clinical trial applications and ethics submissions
Coordination with internal and external stakeholders
Regulatory compliance for clinical trials
Project management and organizational skills
Nice-to-have
Experience with IVDR submissions
Knowledge of Autorité de Sécurité Nucléaire regulations
Process improvement initiatives
Effective cross-functional collaboration
Strong communication and interpersonal skills
Key Requirements
Bachelor's degree in life sciences or related field
Minimum 2 years clinical research or regulatory affairs experience
Experience in study start-up activities
Knowledge of ICH-GCP and local regulatory requirements