Clinical Trial Manager

🔥 18 hours ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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

• Own country and site budgets and develop, negotiate, and complete Clinical Trial Research Agreements (CTRA) • Oversee and track clinical research-related payments, payment reconciliation, compliance checks, financial systems, and financial forecasting • Execute and oversee clinical trial country submissions and approvals for assigned protocols • Develop local-language materials, including informed consents and translations, and interact with IRB/IEC and Regulatory Authority • Manage country deliverables, timelines, results, quality, and compliance for assigned protocols • Contribute to local SOP development and oversee CTCs as applicable • Coordinate with CRM, CTC, CRA, Finance, and Legal to obtain country deliverables for submissions, budgets, CTRAs, and milestones • Collaborate with Headquarters to align country timelines • Support and oversee local vendors • Oversee local processes, clinical and ancillary supplies, import/export requirements, supplies destruction, filing, archiving, retention, and insurance processes • Maintain country information in clinical and finance systems • Own local regulatory and financial compliance, particularly during study start-up • Influence investigators, external partners, and country operations to meet budget targets and payment timelines • Partner with internal country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, and headquarters teams, and external vendors, sites, IRBs/IECs, and Regulatory Authorities • Contribute to or lead business initiatives and projects • Act as a process Subject Matter Expert, share best practices, recommend improvements, and provide training • Mentor colleagues and share best practices

🎯 Requirements

• Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience • 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business • Expertise of core clinical systems, tools and metrics • Excellent verbal and written influencing and training/mentoring skills, in English • Strong coordination and organizational skills • Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up • Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or manager • Ability to make decisions independently with limited oversight from Sr.COM or manager • Requires strong understanding of local regulatory environment • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally • Eligible to work in the United States without visa sponsorship

🏖️ 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