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 • Streamline communication across cross-functional stakeholders and facilitate issue resolution • Act as the primary company contact for assigned trial sites and engage investigators and site staff • Contribute to site feasibility, site qualification visits, site selection, recruitment strategy, contingency planning, and implementation • Coordinate local/country team activities, recruitment targets, study documents, procedures, tools, risk management, and budget forecasting • Maintain trial management systems, analyze trial progress, initiate CAPA when needed, and communicate study status and issues • Manage country-level vendors, vendor services, vendor selection, and site/local vendor invoices • Manage local study supplies when required • Conduct local trial team meetings and facilitate study-monitoring training • Prepare and manage country- and site-specific informed consent forms • Ensure adverse events, serious adverse events, and product quality complaints are reported within required timelines • Maintain inspection readiness, complete trial data and essential documents in CTMS and eTMF/IF, and support archiving • Ensure site data quality and timely query resolution • Support audits, inspections, quality visits, and CAPA implementation • Ensure accurate finance reporting and delivery within budget, including local budget forecasting and 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 • Manage complex Early Phase trials with internal matrix clinical teams and sites, 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 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 • Legally authorized to work in the United States • Must 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 • Reasonable accommodations during the recruitment process • Inclusive and accessible workplace