Clinical Research Associate II - Sponsor dedicated - Belgium - Home based (m/w/d)

IQVIA; Zaventem; On-site; EUR 42,000 - 66,000; Full time

Benefits offered by this job

Company car

Mobile phone

Rewards package

Job summary

IQVIA Belgium is seeking a Clinical Research Associate II for its sponsor-dedicated model. This home-based role focuses on monitoring visits, site management, and ensuring regulatory compliance across Belgian sites.

The CRA will support start-up activities and collaborate with global teams to maintain study integrity. Requires a science degree and at least 18 months of on-site CRA experience, with fluency in Dutch, French and English.

Qualifications

• Minimum 18 months of independent, on-site CRA monitoring experience.
• Excellent communication in Dutch, French and English.
• Solid knowledge of GCP/ICH guidelines and regulatory requirements.
• Strong organizational and problem-solving abilities.
• Collaborative mindset to work with cross-functional teams.

Responsibilities

• Perform site monitoring visits per scope of work and regulatory requirements (GCP/ICH).
• Coordinate site recruitment plans and communicate with sites regularly.
• Administer protocol training and ensure site staff are updated.
• Track regulatory submissions, recruitment, CRF completion and data queries.
• Maintain TMF/ISF documentation and generate study reports.

Skills

Site monitoring

GCP/ICH knowledge

Communication skills

Cross-cultural skills

Education

Science degree

Job description

Clinical Research Associate II - Sponsor dedicated - Belgium - Home based For candidates able to start before December 2026, a discretionary sign‑on bonus of up to 4,300 EUR may be offered, with the final amount confirmed at offer stage, subject to role level and relevant experience. IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. Within our Sponsor dedicated model, our team contributes to the pipelines of the specific sponsor and therefore our CRAs are ‘indication and molecule experts’. We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study. Leadership recognises the skills, talent and experience of our clinical teams and strives to build upon this as the function evolves and grows. Our managers understand the sponsors priorities and the individual aspects of each model. Focus is given to career development from day one, including new hire orientation and onboarding, day to day problem solving and training and development. Additionally, IQVIA’s sponsor dedicated business works with the Sponsors SOP’s, creating more continuity for both parties. Our models offer excellent opportunities for experienced CRA’s to expand their knowledge and skills. IQVIA Belgium are currently seeking motivated Clinical Research Associate II practitioner to join our unique and dynamic Sponsor dedicated model. This is a role based in Belgium

Your Role:

• Perform site monitoring visits (selection, initiation, monitoring and close‑out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• May support start‑up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow‑up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.

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.

Why join us?

• Grow your career with access to development resources, training, and advancement opportunities
• Enjoy the flexibility and trust to balance your professional and personal commitments
• Expand your therapeutic knowledge through dedicated learning and development programs
• Be part of a successful global organization with an excellent reputation and supportive culture
• Benefit from a company car, mobile phone, and an attractive rewards and benefits package

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.

No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.