Senior Clinical Research Lead Global MedTech Trials

BD; Erembodegem; Sur place; EUR 60 000 - 92 000; Plein temps

Résumé du poste

BD Peripheral Intervention is recruiting a Senior Clinical Research Associate to lead site management for global medical device studies. You will act as the primary site contact, drive performance, ensure regulatory compliance, and support data quality and timely study delivery.

This role suits a clinical research professional who thrives in a dynamic environment, collaborates with cross-functional teams, and has extensive experience in site monitoring and regulatory guidelines.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum of 5 years of clinical research experience in medical devices, pharma, or biotech.
• Minimum of 4 years in site management, monitoring, or clinical project management.
• Strong knowledge of ICH-GCP, ISO 14155, and global regulations.
• Familiarity with eTMF, CTMS, and CDMS platforms.
• Willingness to travel up to 60%+ during peak periods.
• Experience in peripheral vascular disease, kidney disease, and/or oncology studies.
• Previous medical device clinical research experience.
• Proficiency with Veeva Vault CTMS, CDMS, and eTMF.
• Professional certification (ACRP, SOCRA, or equivalent).
• Fluent in Dutch, English and German.

Responsabilités

• Lead site management from qualification to close-out.
• Build relationships with investigators and site staff.
• Conduct on-site and remote monitoring per protocols and GCP/ISO 14155.
• Drive site activation, enrollment, retention, and performance.
• Identify risks and implement mitigation strategies.
• Ensure data quality and protocol compliance.
• Review and contribute to study documentation.
• Support audits and inspections and resolve findings.
• Collaborate with Clinical Project Managers and cross-functional teams.
• Contribute to process improvements and monitoring tools.

Connaissances

Dutch (Fluent)

English (Fluent)

German (Fluent)

Formation

Bachelor's degree in Life Sciences

Outils

Veeva Vault CTMS

CDMS

eTMF

Description du poste

BD Peripheral Intervention is recruiting a Senior Clinical Research Associate to lead site management for global medical device studies. You will act as the primary site contact, drive performance, ensure regulatory compliance, and support data quality and timely study delivery.

This role suits a clinical research professional who thrives in a dynamic environment, collaborates with cross-functional teams, and has extensive experience in site monitoring and regulatory guidelines.