Senior Clinical Trial Manager

🕒 4 days ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution • Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams • Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report • Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial • Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations • Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial • Focuses on investigator engagement through timely follow up with sites • Promptly communicates relevant status information and issues to appropriate stakeholders • Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress • When necessary initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team • Deliver competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection • Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed • Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate • Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals in cooperation with the local Start Up team, as applicable

🎯 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 • To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, 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