Senior Clinical Research Associate

This is a fully remote position, open to applicants in Belgium, +2 more states.

📋 Description

• Oversee site management activities from the qualification and initiation stages through to study completion.

• Establish and nurture relationships with investigators, study coordinators, and site staff.

• Perform on-site and remote monitoring visits in accordance with protocols, GCP, ISO 14155, and relevant regulations.

• Propel site activation, patient enrollment, retention, and overall site performance.

• Recognize risks and operational hurdles, implementing strategies for mitigation.

• Ensure the accuracy, completeness, quality, and compliance of clinical data with protocols.

• Review and assist in the development of essential clinical study documentation.

• Aid in audits and inspections, addressing site management and monitoring findings.

• Collaborate with Clinical Project Managers and cross-functional teams.

• Contribute to process enhancements, sharing best practices, and improving clinical monitoring tools and resources.

⛳️ Requirements

• Bachelor's degree in Life Sciences or a related discipline, or a comparable mix of education and experience.

• At least 5 years of experience in clinical research within the medical device, pharmaceutical, or biotechnology sectors.

• A minimum of 4 years in site management, monitoring, and/or clinical project management.

• Solid understanding of both domestic and international clinical research regulations, ICH-GCP, ISO 14155, and industry best practices.

• Familiarity with eTMF, CTMS, and CDMS systems.

• Willingness and capability to travel up to 60% or more during peak study periods.

• Experience in supporting studies related to peripheral vascular disease, end-stage kidney disease, and/or oncology.

• Prior involvement in medical device clinical research.

• Proficient in Veeva Vault CTMS, CDMS, and eTMF.

• Professional certification through ACRP, SOCRA, or a similar organization.

• Fluent in Dutch, English, and German.

🏝️ Benefits

• Comprehensive Total Rewards program.

• Opportunities for rewards and recognition.

• Competitive compensation and benefits packages.

• In-person collaboration that fosters learning, progress, and success.

• Certified as a Top Employer 2026 working environment.

• Equal Opportunity Employer.