Senior Clinical Research Associate (MedTech) – 80% Travel

Pauwels Consulting; Machelen; Sur place; EUR 75 000 - 95 000; Plein temps

Résumé du poste

Pauwels Consulting seeks a Senior Clinical Research Associate to manage clinical study activities across multiple sites in the MedTech field. You will oversee site performance, conduct monitoring visits, and ensure high-quality data collection for diverse medical device projects.

This role requires a life sciences or nursing degree, 4+ years of site monitoring, strong GCP knowledge, and fluency in English and Dutch.

Qualifications

• Bachelor degree in Life Sciences, Nursing, or related field.
• 4+ years of site monitoring experience in clinical research for medical devices.
• Strong knowledge of GCP and regulatory standards for medical devices.
• Experience with computer systems including MS Office.
• Willing to travel up to 80%.
• Fluent in English and Dutch.

Responsabilités

• Manage clinical study activities and site performance for multiple projects according to overall project timelines.
• Conduct site visits, monitoring, and communication to ensure compliance with study protocols and regulatory requirements.
• Oversee the maintenance of Investigator Site Files and ensure the safety and well-being of study subjects are maintained.
• Support patient recruitment and retention activities while resolving site-level issues through corrective and preventive actions.
• Execute clinical trials in alignment with established standard operating procedures, GCP, and relevant regulatory standards.
• Collaborate with investigators, IRBs/ECs, and vendors to support the implementation of new clinical systems and processes.

Connaissances

English fluency

Dutch fluency

Leadership

Organizational skills

Willing to travel

MS Office

Formation

Bachelor degree in Life Sciences or related

Outils

MS Office

Description du poste

Pauwels Consulting seeks a Senior Clinical Research Associate to manage clinical study activities across multiple sites in the MedTech field. You will oversee site performance, conduct monitoring visits, and ensure high-quality data collection for diverse medical device projects.

This role requires a life sciences or nursing degree, 4+ years of site monitoring, strong GCP knowledge, and fluency in English and Dutch.