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Senior Clinical Trial Manager

🔥 0 minutes ago

🔔 Pennsylvania – Remote

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⏰ Full Time

đźź  Senior

đź§Ş Clinical Research

đź‘» Ghost score 10%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

đź’Ľ 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.

đź“‹ Description

• Serve as a site-aligned end-to-end partner throughout trial lifecycles • Serve as the primary point of communication for assigned trial sites and facilitate internal client teaming to drive issue resolution • Own relationships with critical site stakeholders and provide a voice for sites to client teams • Contribute to site feasibility, site qualification visits, follow-up, and final site selection • Coordinate local team activities to meet recruitment targets, maintain high-quality data, and remain within budget and compliance requirements • Engage investigators and site staff throughout the trial and communicate status information and issues to stakeholders • Maintain and update trial management systems and analyze trial progress • Initiate CAPA when trials deviate from plans and communicate progress and issues to study management and Quality & Compliance teams • Contribute to site-level recruitment strategy, contingency planning, and implementation • Manage country-level vendors, invoices, vendor selection, and local study supplies as required • Conduct local trial team meetings and facilitate monitoring training when needed • Prepare and manage country-specific and site-specific informed consent forms • Ensure AEs, SAEs, and PQCs are reported within required timelines • Maintain inspection readiness through complete and timely trial data and essential documents in CTMS and eTMF/IF • Ensure site data quality and timely query resolution • Maintain therapeutic knowledge and complete relevant training requirements • Support CAPA implementation for audits, inspections, and quality-related visits • Ensure accurate financial reporting, budget forecasting, and proactive country/local trial budget management • Organize and ensure IEC/HA approvals with the local Start Up team • Contribute to systems/process training and functional process initiatives • Submit timely and accurate time reports • Manage complex Early Phase trial startup and projections with internal matrix clinical teams and sites, as applicable • Execute local trial management services autonomously and provide process leadership

🎯 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 • 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

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