Senior Clinical Trial Manager

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Serve as a site-aligned end-to-end partner throughout trial lifecycles and streamline communication across cross-functional stakeholders • Act as the primary point of communication for assigned trial sites and facilitate internal client teaming to resolve issues • Own relationships with critical site stakeholders and provide site perspectives to client teams • Contribute to site feasibility, site qualification visits, site selection, and follow-up reporting • Coordinate local and country team activities to meet recruitment targets, deliver high-quality data on time, and remain within budget • Develop local trial procedures and tools, recruitment plans, contingency and risk management, and budget forecasts as needed • Engage investigators and site staff throughout the trial and communicate status information and issues to stakeholders • Maintain and update trial management systems and use study tools and management reports to analyze trial progress • Initiate and communicate corrective and preventive actions when trials deviate from plans • Contribute to site-level recruitment strategy and contingency planning • Manage country-level vendors, vendor services, selection, and applicable invoices • Manage local study supplies as required • Conduct local trial team meetings and facilitate study-monitoring training • Prepare and manage country-specific and site-specific informed consent forms • Ensure adverse events, serious adverse events, and protocol quality complaints are reported within required timelines • Maintain complete, accurate, and timely trial-management data and essential documents for inspection readiness and archiving • Escalate deviation issues and ensure site data quality and query resolution • Work with Study Managers on CAPA implementation for audits, inspections, and quality-related visits • Conduct accompanied site visits when delegated by the Sponsor • Ensure accurate finance reporting, budget forecasting, and proactive local trial budget management • Assist with trial site contract and budget negotiations when applicable • Organize and ensure IEC/HA approvals with the local Start Up team • Provide systems/process training and contribute to process initiatives when applicable • Complete timely and accurate time reporting • Execute local trial management services autonomously and provide process leadership

🎯 Requirements

• BA/BS degree required • Degree in a health or science related field • 3–5+ years of trial end-to-end management experience • Start-up and 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 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 • Must be legally authorized to work in the United States • Must not require now or in the future sponsorship for employment visa status • Experience in management and startup of complex Early Phase trials with internal matrix clinical teams and sites, as applicable

🏖️ 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 • Inclusive and accessible workplace • Reasonable accommodations during the recruitment process