Senior Clinical Research Associate

🔥 18 hours ago

🌐 Belgium, Netherlands – Remote

🇧🇪 Belgium – Remote 🇳🇱 Netherlands – Remote

⏳ Contract/Temporary

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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.

📋 Description

• Take ownership of investigative sites from site activation through study close-out • Conduct Site Qualification Visits, Site Initiation Visits, routine Monitoring Visits, Quality Oversight Visits, co-monitoring visits, and Close-Out Visits • Ensure site compliance with study protocols, ICH-GCP guidelines, and applicable regulatory requirements • Verify source documentation, informed consent processes, investigational product accountability, and essential regulatory documentation • Identify, document, communicate, and escalate protocol deviations, compliance concerns, and study risks • Ensure study milestones are achieved according to timelines, including site activation, patient recruitment, database analyses, and study close-out • Build and maintain relationships with investigators and site personnel • Ensure site staff are appropriately trained and qualified throughout the study • Prepare monitoring reports, follow-up letters, and study documentation • Collaborate with cross-functional teams, study management, and sponsor stakeholders • Support audit and inspection readiness activities

🎯 Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field • Minimum 3–5 years of independent clinical monitoring experience as a CRA • Minimum 1 year of experience in Ophthalmology, especially retinal diseases such as Age-Related Macular Degeneration (AMD), Geographic Atrophy (GA), Diabetic Retinopathy, Diabetic Macular Edema, and Inherited Retinal Disorders • Experience with Gene Therapy or Advanced Therapy programs • Strong knowledge of ICH-GCP, clinical trial regulations, and monitoring practices • Fluency in Dutch at native or bilingual level • Professional proficiency in English

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment