Clinical Study Associate

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🕒 Yesterday

🌐 India, Costa Rica, +2 more countries – Remote

🇮🇳 India – Remote 🇨🇷 Costa Rica – Remote 🇰🇪 Kenya – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Associate

👻 Ghost score 10%

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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

• Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with FSP CTA Manager(s) • Collaborate with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model • Perform departmental tasks as needed • Review study documentation, including essential document packets, study plans, and informed consent forms • Support and oversee risk-based monitoring • Attend key team meetings as required, including preparing minutes for selected studies • Support regulatory inspection readiness, including SOP lists and storyboard collation • Support clinical trial systems such as CTMS/TMF and associated activities for selected studies • Support vendor contract administration as required • Support study close-out activities, including financial reconciliation • Support additional ad-hoc activities as needed, as agreed with Manager(s) • Collaborate with internal departments, CROs, and external vendors

🎯 Requirements

• Bachelor's degree in a scientific or healthcare-related field or equivalent international degree required • 1-2 years’ experience in pharmaceutical industry, clinical research organization, or related role • Experience in Phase 2 and 3 studies and global/international studies is advantageous • Must have experience in Veeva system • Experience working across multiple therapeutic areas (including oncology) is advantageous • Knowledge in global/regional regulatory and compliance requirements for clinical research • Demonstrated excellence in task management and cross-functional collaboration • Excellent communication skills • Excellent teamwork, organizational, interpersonal, and problem-solving skills • Fluent business English (oral and written) • Ability to work collaboratively in a fast-paced environment with attention to detail • Willingness to travel as required (approximately 10%) • Employment with ICON is contingent upon having the 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