Clinical Site Manager

Clinical Monitoring I CRA I Early Phases

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.

For our client in the Antwerp region, we are looking for a Clinical Research Associate (Site Manager) to join our ICON team! You will be working for one of the most attractive employers in Belgium, creating a real impact on the health of patients worldwide.

As a CRA your main responsibilities will be to provide trial coordination and site management services for your assigned studies/sites. For this you will independently ensure that your sites are inspection read at all times, perform pretrial assessment, site selection, subject recruitment and retention planning, site initiation, monitoring and close-out.

What you will be doing

• Perform site qualification, site initiation, and closeout visits, ensuring regulatory and protocol compliance. Visits may be on-site or remote.
• Generate queries and manage resolutions with site personnel.
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs and other required study documents as per SOPs and Study Monitoring Plan.
• Perform investigational product accountability as per the protocol and Study Monitoring Plan.
• Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected.
• Act as primary liaison with site personnel.
• Management and collection of site's study regulatory documents.
• Enter data into tracking systems as required.
• Assist and support audit preparation and CAPA implementation.
• AE/SAE and expedited reporting and management.

Your profile

• Degree in a health or sciences related field
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Proven experience in on-site monitoring of clinical studies is a must. Minimum experience of 3 years.
• Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus.
• Proven ability to work independently in a fast-paced environment.
• Strong communication, interpersonal, and organizational skills.
• Must demonstrate good computer skills.
• Fluently Dutch, French and English

#LI-Hybrid
#LI-VV1

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply