Clinical Operations Specialist

ICON Strategic Solutions is a global clinical research organization that provides sponsor-dedicated support for clinical trials. The Clinical Operations Specialist contributes to site start-up and activation activities by preparing regulatory submissions, coordinating stakeholders, maintaining study records, advising study teams, and improving start-up processes.

Responsibilities

Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications

Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation

Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence

Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities

Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs.

Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Company

Outsourced clinical development and commercialization services for life sciences

Dublin , GB

https://www.iconplc.com/services/strategic-solutions/

10001+ employees

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

Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.

Required skills

Clinical Research, Study Start-Up, Regulatory Affairs, ICH-GCP, Local Clinical Trial Regulations

Preferred skills

Project Management

Experience

2+ years