Senior Clinical Trial Manager

🕒 July 13

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Senior Local Operations Manager role aligned with site and cross functional stakeholders throughout trial lifecycles • Primary point of communication for sites, facilitating internal client teaming to drive issue resolution • Understands site operational model and owns relationships with critical site stakeholders • Contributes to quality Site Selection through site feasibility and site qualification visits • Collaborates with central study team and local stakeholders for final selection of trial sites • Ensures local/country team meets recruitment targets with high quality data on time and within study budget • Acts as primary company contact for assigned trial sites • Focuses on investigator engagement through timely follow up with sites • Maintains and updates trial management systems, drives study compliance and communicates status to stakeholders • Delivers vendor management at the country level to support the study • Ensures high standards for study monitoring and conducts quality local trial team meetings • Prepares country specific informed consent according to procedural documents • Ensures trial subject safety and timely reporting of AEs/SAEs/PQCs • Keeps inspection ready with completed data in systems utilized for trial management • Conducts accompanied site visits and assists in negotiation of trial site contracts if applicable • Maintains accurate finance reporting and trial delivered within budget by managing local trial budget

🎯 Requirements

• BA/BS degree • Degree in a health or science related field • 3 - 5+ years of trial end to end management experience • Start-up & Database Locks/Cleaning experience preferred • Solid Tumor Oncology experience required • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures • Strong IT skills in appropriate software and company systems • Proficient in speaking and writing the country language and English • Good written and oral communication skills as appropriate • Applicants must be legally authorized to work in the United States and should not require sponsorship for employment visa status

🏖️ 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