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 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, site selection, recruitment strategy, contingency planning, and implementation • Coordinate local/country team activities to meet recruitment targets with high-quality data, on time, and within budget • Act as the primary company contact for investigators and site staff throughout the trial • Maintain and update trial management systems, analyze trial progress, and initiate CAPA when trials deviate from plans • Communicate study progress, issues, status information, and deviations to study management, Quality & Compliance, TDM/TDL, and sponsor stakeholders • Manage country-level vendors, vendor services, vendor selection, invoices, and local study supplies as required • Conduct quality 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 concerns are reported within required timelines • Maintain complete and accurate trial data and essential documents in CTMS and eTMF/IF for inspection readiness and archiving • Ensure site data quality and timely query resolution • Support CAPA implementation for audits, inspections, and quality-related visits • Conduct accompanied site visits with study monitors when delegated by the sponsor • Forecast and proactively manage country/local trial budgets and ensure accurate finance reporting • Assist with trial site contract and budget negotiations when applicable • Organize and ensure IEC/HA approvals with the local Start Up team • Contribute to systems/process training and functional process initiatives • Complete timely and accurate time reporting • Manage and start up complex Early Phase trials with internal matrix clinical teams and sites as applicable

🎯 Requirements

• BA/BS 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 as appropriate • Must be legally authorized to work in the United States • Must not require now or in the future sponsorship for employment visa status • Must have the legal right to work in the country where the role is based • Must comply with relevant training requirements and develop sufficient therapeutic knowledge for the role

🏖️ 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