(Senior) Clinical Research Associate

Clinical Site Manager I CRA I Senior CRA

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

📌 Job Opportunity: Clinical Site Manager / Senior CRA

We are looking for an experienced clinical research professional who is passionate about partnering with study sites, safeguarding study quality, and driving successful clinical trial execution.
In this role, you will combine strong monitoring expertise with a proactive focus on site engagement, study oversight, and quality performance. This role is sponsor-dedicated (remote) with focus on Belgium and the Netherlands.

🔍 Key Responsibilities

Site Qualification & Study Start-up

• Assess the suitability and qualifications of potential clinical study sites.
• Lead site initiation activities and ensure site personnel are fully trained on the protocol, amendments, study systems, and operational requirements

Study Conduct & Monitoring

• Manage the day-to-day conduct of clinical studies at assigned sites, ensuring compliance with:
• Study protocol and protocol amendments
• Good Clinical Practice (GCP)
• ICH guidelines
• Company SOPs and all relevant regulatory requirements
• Perform evaluation, routine monitoring, and close-out visits, documenting all activities through clear, accurate Monitoring Visit Reports, Contact Reports, and follow-up letters within required timelines.

Site Relationship Management

• Serve as the primary point of contact for investigators and site staff, acting as the key liaison between the site and the sponsor study team.
• Provide ongoing training or retraining to site personnel when needed to ensure high-quality study execution.

Data Quality & Patient Safety

• Evaluate the integrity and accuracy of site-reported data and ensure timely data entry and query resolution in the EDC system.
• Support data validation and cleaning processes to meet study timelines.
• Ensure patient rights, safety, and well-being are always protected.
• Oversee adherence to safety reporting requirements for adverse and serious adverse events.

Performance Oversight & Issue Management

• Develop and support patient recruitment strategies to help sites meet enrollment goals.
• Identify site-level performance, quality, or compliance issues and implement appropriate corrective or preventive action plans.

💼 Why This Role Matters

You will play a critical role in ensuring high-quality clinical trial execution while strengthening relationships with clinical sites. Your expertise will directly contribute to reliable study outcomes, improved site performance, and exceptional patient care.

👤 Profile / Requirements

We are seeking a candidate who brings both expertise and strong interpersonal skills:

• Prior experience as a Clinical Research Associate, Clinical Site Manager, or a similar monitoring-focused role
• Educational background in Life Sciences (e.g., Biomedical Sciences, Pharmacy, Nursing, Biology, etc.)
• Solid understanding of GCP, ICH guidelines, and clinical trial operations
• Excellent communication and relationship-building skills
• Strong language skills in Dutch, French, and English (both written and verbal)
• Ability to work independently, show initiative, and take ownership of site performance
• Strong organizational skills and attention to detail
• Problem-solving mindset with the ability to address site-related challenges proactively 

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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