Senior Unblinded Clinical Research Associate

🔥 1 hour ago

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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

• Conduct unblinded site qualification, initiation, routine monitoring, and close-out visits at local and international sites, specifically Singapore • Oversee pharmacy processes and Investigational Product management • Ensure protocol compliance, IP accountability, temperature log verification, and patient safety while maintaining trial blinding • Collaborate with site pharmacists and pharmacy staff on study conduct, unblinded dispensing, and IP disposal or return • Perform unblinded data reviews, pharmacy documentation checks, and resolve pharmacy queries in restricted-access spaces • Prepare and review unblinded study documentation, including pharmacy manuals, unblinded monitoring plans, and IP destruction logs

🎯 Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a healthcare-related field • Minimum of 2 years of experience as a Clinical Research Associate, including independent site monitoring visits • In-depth knowledge of clinical trial processes and unblinded monitoring procedures • Knowledge of local regulations, including HSA Singapore guidelines, and ICH-GCP guidelines • Strong organizational, integrity-driven, and communication skills • Meticulous attention to detail regarding Investigational Product management • Ability to work independently and maintain strict blinding firewalls in a fast-paced environment • Willingness and flexibility to travel as required, including regular regional travel to Singapore • Registered Pharmacist license preferred

🏖️ 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