TFS HealthScience
TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.
CRO • clinical trials • Scientific and Medical consulting • Contract Placement Solutions (staffing) • Regulatory Consulting
Senior Clinical Research Associate
February 24
TFS HealthScience
TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.
CRO • clinical trials • Scientific and Medical consulting • Contract Placement Solutions (staffing) • Regulatory Consulting
📋 Description
• Lead site monitoring activities for ophthalmology trials, ensuring adherence to protocol, GCP, and regulatory requirements. • Implement risk-based approaches to ensure proactive issue resolution and maintain trial quality. • Manage ethics committee submissions, amendments, and periodic regulatory reporting, including safety event notifications. • Contribute to site activation, including Site Initiation Visits (SIVs) and investigator training. • Ensure proper trial documentation, monitor data integrity, and support study closeout.
🎯 Requirements
• Prior experience in clinical trial monitoring within a CRO, biotech, or pharmaceutical company. • Therapeutic expertise in ophthalmology trials. • Experience in retinal disorders. • Gene therapy experience is a plus but not required. • Familiarity with local and international regulatory requirements. • Strong interpersonal skills to engage effectively with sponsors and site staff.
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