[Hiring] Clinical Operations Specialist @ICON plc

Role Description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

• Contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.
• Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
• Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
• Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
• Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Qualifications

• Bachelor's degree in life sciences or a related field.
• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
• Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Willingness to travel as required (approximately 5%).

Requirements

• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

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.
• Benefits may vary depending on role and location.

Company Description

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply.