Clinical Research Associate II - IQVIA Biotech - Belgium - Home based (m/w/d)

IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we are in is cutting edge for therapies with un-met medical need.

IQVIA Biotech has an exciting position within its EU Clinical Monitoring team. The Clinical Monitoring department is the largest team within IQVIA Biotech, providing CRA, Clinical Leads, Management and oversight to global clinical studies.

IQVIA Belgium are currently seeking motivated Clinical Research Associate II practitioner to join our unique and dynamic Biotech model.

This is a role based in Belgium

Build Your Future with IQVIA 

At IQVIA, you'll apply your clinical research expertise to drive meaningful outcomes for patients and sponsors around the world. As a Clinical Research Associate, you'll work across innovative studies and therapeutic areas, build your reputation with leading pharmaceutical and biotechnology partners, and grow your skills through structured training, mentorship, and genuine global career pathways. If you're ready to take ownership of site relationships, sharpen your expertise, and help bring life-changing treatments to patients worldwide, we'd love to hear from you. 

Key responsibilities 

• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, GCP, ICH guidelines, and applicable regulatory requirements. 

• Ensure investigational sites maintain high standards of patient safety, data integrity, protocol compliance, and study quality. 

• Build and maintain effective relationships with investigators and site personnel, providing ongoing guidance, training, and support throughout the study lifecycle. 

• Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution, and site performance metrics. 

• Collaborate with sites to implement and optimize patient recruitment and retention strategies to support study timelines. 

• Maintain accurate, complete, and inspection-ready study documentation, including Investigator Site Files (ISF), Trial Master Files (TMF), monitoring reports, and follow-up communications. 

• Identify, assess, and appropriately escalate study risks, site issues, and quality concerns while driving timely resolution. 

• Partner closely with cross-functional study teams to support successful study execution and delivery of project objectives. 

• Mentor and support junior clinical team members through coaching, training, and co-monitoring activities, as applicable. 

• Contribute to continuous improvement initiatives and support study start-up, maintenance, close-out, and site financial activities as required. 

Your Profile:

• University degree in scientific discipline or health care
• Minimum of 18 months of independent, on-site monitoring experience as a CRA within a CRO or pharmaceutical environment.
• Excellent communication skills in Dutch, French, and English, both written and spoken.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines). Organizational and problem-solving skills.
• Exceptional interpersonal and cross-cultural communication skills to build strong, trusted partnerships with Belgium site investigators and medical staff.
• A collaborative mindset to work effectively with cross-functional global teams, project managers, and local study coordinators.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.