ICF Manager

Job not on LinkedIn

🕒 May 23

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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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

• Take ownership of the end-to-end development and management of Master Informed Consent Forms (ICFs) for clinical trials • Ensure processes are efficient, high-quality, and fully compliant with global regulatory standards • Streamline ICF workflows, reducing turnaround times • Support study teams to deliver impactful clinical research • Provide subject matter expertise in ICF development, using company templates, processes, and systems • Prepare study-level Master ICFs from draft to final approval, collaborating with CSM, SSU Manager, CRO, and other stakeholders • Support country- and site-specific ICF reviews and manage amendments • Ensure ICF content aligns with study protocols, schedules of events, and regulatory requirements • Act as SME for ICF processes, systems, and workflows • Assist with follow-up to audit findings and CAPAs related to ICFs

🎯 Requirements

• 4+ years in the pharmaceutical or clinical research industry • 2+ years in study start-up and ICF development • Ability to interpret study protocols and schedules of assessments to develop accurate ICFs • Strong teamwork, organizational, and problem-solving skills • Proficiency in Microsoft Office and document management systems • Knowledge of global regulatory and compliance requirements for clinical research (e.g., US CFR, EU CTD, ICH GCP) • Experience in project or program management, including risk identification and mitigation • Fluent business English, written and spoken • Clinical background (e.g., RN) or familiarity with patient-facing documentation is a plus • Experience with Veeva is advantageous

🏖️ 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