Quality Review Junior Associate
Posted Oct 10
Posted Oct 10
This is a fully remote position, open to applicants in Mexico.
• Oversee the management of Trial Master File (TMF) documentation in alignment with client specifications and ICON protocols.
• Ensure the TMF documentation is complete, accurate, and submitted in a timely manner throughout the clinical trial lifecycle.
• Collaborate with cross-functional teams to gather, evaluate, and preserve vital documents for regulatory submissions.
• Perform quality assessments and audits of TMF documents to guarantee adherence to regulatory standards and sponsor expectations.
• Offer support and guidance to both internal and external stakeholders regarding TMF-related issues.
• At least 3 years of experience in clinical research or document management within the pharmaceutical, biotechnology, or CRO sectors.
• Bachelor's degree in life sciences, documentation management, or a related field.
• Exceptional attention to detail and organizational abilities, with the capacity to handle multiple tasks concurrently.
• Strong communication skills, with the ability to collaborate effectively with cross-functional teams.
• Openness to travel as necessary (approximately 5%).
• Employment with ICON is subject to possessing the legal right to work in the country where the position is located.
• Competitive base salary along with performance-related incentives.
• Health and wellness programs, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life insurance and disability coverage.
• Employee assistance programs and wellness resources.
• Opportunities for learning and development through structured training and career pathways.
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