Clinical Study Assistant

đŸ”„ 17 hours ago

đŸ‡ČđŸ‡œ Mexico – Remote

⏰ Full Time

🟱 Junior

✹ Clinical Assistant

đŸ‘» Ghost score 10%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

đŸ’Œ Consulting

đŸ„ 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

‱ Perform tasks related to the planning and execution of clinical studies as a Clinical Study Assistant exclusively assigned to a Pharmaceutical Company ‱ Support critical day-to-day clinical study activities, including regulatory inspection readiness, under the general supervision of the FSP Manager and in collaboration with CTA Managers ‱ Collaborate with Clinical Operations/Study Managers, study teams, and CROs ‱ Perform departmental tasks as needed ‱ Review study documentation, including essential document packets, study plans, and informed consent forms ‱ Support or oversee risk-based monitoring ‱ Attend key team meetings and prepare 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 ‱ Support vendor contract administration ‱ Support study close-out activities, including financial reconciliation ‱ Support additional ad-hoc activities as agreed with managers ‱ Collaborate with Legal, Insurance, R&D functions, 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 ‱ 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%) ‱ Legal right to work in the country where the role is based

đŸ–ïž 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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