Risk Based Study Manager

Job not on LinkedIn

🔥 55 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🎲 Risk

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 21 days.
• No salary listed.

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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

• Lead and maintain study‑level risk assessments for assigned sponsor studies • Facilitate and chair cross‑functional risk review meetings, ensuring focus on critical data and processes • Drive proactive identification, discussion, and documentation of study risks • Partner closely with the CRM and study team to ensure aligned oversight and follow‑through on mitigation actions • Review centralized monitoring outputs, KRIs, KPIs, and trends to detect emerging or systemic risks • Support issue escalation, root cause analysis, and risk mitigation planning • Ensure risk‑based activities align with set principles and sponsor expectations • Contribute to inspection readiness through clear documentation and defensible oversight decisions

🎯 Requirements

• Experience in clinical trial operations, study management, monitoring, or centralized oversight • Solid understanding of risk‑based monitoring and study management principles • Knowledge of ICH‑GCP, regulatory standards, and quality frameworks • Strong facilitation skills with confidence leading cross‑functional discussions • Analytical mindset with the ability to interpret data, trends and signals • Excellent communication and stakeholder management skills • Ability to operate independently while collaborating effectively with sponsor and ICON team • Legal right to work in the country where the role is based

🏖️ 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

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