Manager, Clinical Operations

🔥 25 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge • Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies • Provide input into global subject/patient recruitment plans • Relationship management between study sites and vendors • Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight • Manage strategic study operations including: study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc • Create and update critical trial-specific documents (for example country specific ICF) and plans • Support development of compound and protocol level training materials • Review and provide input into budgets, timelines, and forecasts for assigned clinical studies • Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups • Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level • Participate in process improvement activities at a trial and department level as needed

🎯 Requirements

• BS/ BA Degree is required • 5+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials • 2-3+ years leading aspects of global clinical trials • Experience working with a CRO • Strong regulatory knowledge, including Good Clinical Practices (GCPs) • Strong decision-making, analytical and financial management skills are essential to this position • Proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision • Experience in leading without authority and in multifunctional matrixed and global environments • Experience mentoring/ coaching others • Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability • Strong project planning/ management, communication (written and verbal) and presentation skills • Experience with protocol, ICF, CRF, CSR development and review • Proficient with MS Office Suite (Excel, Word and PowerPoint)

🏖️ 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