Lead Clinical Research Associate

ICON plc

Lead Clinical Research Associate overseeing and managing clinical trial sites at ICON plc. Ensuring studies comply with regulations and protocols while developing team capabilities.

Posted 4/25/2026full-timeRemote • 🇷🇴 RomaniaSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Oversee and manage clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards.
Coordinate clinical trial monitoring delivery, resolving issues, and developing team capability.
Lead and oversee site management activities, including site selection, initiation, monitoring, and close-out visits, ensuring compliance with study protocols, SOPs, ICH-GCP, and applicable regulatory requirements.
Serve as the primary point of contact for the sponsor, ICON CRAs, and clinical sites, providing effective communication, resolving site-level issues, and maintaining strong site relationships to support study success.
Provide ongoing oversight of study progress through regular review of study metrics, KPIs, risks, and escalations.
Support and guide the CRA team by reviewing monitoring reports, providing regular feedback, and conducting co-monitoring visits as needed.
Work closely with the Study Manager to ensure alignment on study timelines, deliverables, and quality expectations, contributing to high-quality trial execution.
Oversee and support CRA responsibilities related to site performance and subject recruitment.
Monitor KPIs and metrics to ensure performance is within expectations, set clear site expectations, and follow up on timely and effective action plans.
Mentor and develop CRAs, supporting their professional growth and promoting consistent application of best practices across studies.

Requirements

What you’ll need

Bachelor's degree in a relevant scientific discipline or healthcare-related field
Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively.
Extensive experience as a Senior Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials.
Prior experience in monitoring of cardiology & obesity clinical trials would be an advantage
In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues.
Willingness to travel as required

Benefits

Comp & perks

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial managementmonitoringsite selectionsite initiationsite monitoringsite close-outKPI monitoringrisk managementstudy protocol compliancementoring

Soft Skills

leadershipmentoringcommunicationorganizationalproblem-solvingteam managementrelationship managementproactive approachmotivationcollaboration