Quality Review Junior Associate

Job not on LinkedIn

🔥 16 hours ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

✨ Associate

👻 Ghost score 10%

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Logo of ICON plc

ICON plc

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

• Manage Trial Master File (TMF) documentation in accordance with client requirements and ICON procedures • Ensure the completeness, accuracy, and timeliness of TMF documentation throughout the lifecycle of clinical trials • Partner with cross-functional teams to collect, review, and maintain essential documents for regulatory submissions • Conduct quality checks and audits of TMF documents to ensure compliance with regulatory standards and sponsor requirements • Provide efforts and guidance to internal and external stakeholders on TMF-related matters

🎯 Requirements

• A minimum of 3 years of experience in clinical research or document management within the pharmaceutical, biotechnology, or CRO industry • Bachelor's degree in life sciences, documentation management, or a related discipline • Strong attention to detail and organizational skills, with the ability to manage multiple tasks simultaneously • Excellent communication skills, with the ability to partnership effectively with cross-functional teams • Willingness to travel as required (approximately 5%) • 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

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