Study Start Up Associate II

ICON plc • Montreal, QC

4d • Remote

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in facilitating the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNovative treatments and therapies.

Requirements

• Bachelor's degree in life sciences or a related field.
• 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.

Nice To Haves

• Previous experience in clinical research or regulatory affairs is preferred.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level