Senior Clinical Research Associate

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

Our client, a leading player in the MedTech industry, is seeking a Senior Clinical Research Associate to manage clinical study activities across multiple sites. This role focuses on overseeing study site performance, conducting comprehensive monitoring visits, and ensuring high-quality data collection for various medical device projects.

Responsibilities

• 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.

Requirements

• You have a Bachelor degree in Life Sciences, Nursing, or a related field.
• You have 4+ years of recent experience in site monitoring within clinical research, specifically for medical devices.
• You possess a strong understanding of GCP and regulatory standards applied to medical devices and combination products.
• You bring experience working with computer systems including Microsoft Office (Excel, Word, and PowerPoint).
• You're characterized by leadership abilities and strong organizational skills to manage multiple tasks and deadlines simultaneously.
• You are willing to travel up to 80% of the time to support site visits and clinical activities.
• You are fluent in English and Dutch with the ability to converse and review medical documentation.

Nice to Haves

• Industry certifications such as CCRA, RAC, or CDE.
• Clinical or medical background.
• Working knowledge of French.