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 company contact for assigned trial sites and maintain investigator and site staff engagement • Contribute to site feasibility, site qualification visits, follow-up reporting, and final site selection • Coordinate local and country team activities to meet recruitment targets, deliver quality data on time, and remain within budget • Develop recruitment plans, contingency and risk management plans, local procedures, tools, and budget forecasts • Maintain trial management systems and analyze reports to drive study compliance and trial progress • Initiate and communicate corrective and preventive actions when trials deviate from plans • Manage country-level vendors, vendor services, selection, and applicable invoices • Manage local study supplies when required • Conduct local trial team meetings and facilitate monitoring training when needed • 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-ready, accurate, complete, and timely trial data and essential documents in CTMS and eTMF/IF systems • Escalate deviation issues and ensure site data quality and query resolution • Support CAPA implementation for audits, inspections, and quality-related visits • Ensure accurate financial reporting, country/local budget forecasting, and proactive 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 • 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 end-to-end trial 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 • 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