Study Start Up Associate II facilitating initiation of clinical trials in regulatory compliance at ICON. Ensuring approvals and developing study documents within a diverse team.
Responsibilities
Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
Maintaining accurate and up-to-date records of regulatory submissions and approvals.
Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
Participating in study start-up meetings and providing input on regulatory requirements and timelines.
Requirements
Bachelor's degree in life sciences or a related field
Previous experience in clinical research or regulatory affairs is preferred
1+ years of Study Start-Up (SSU) experience
Strong attention to detail and organizational skills
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment
Advanced French communication skills, including fluent verbal interactions and strong written proficiency for study documents and regulatory communications.
Benefits
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
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