Senior CRA: Cardiac Trials | Remote

MANTU GROUP SA; Belgique; Sur place; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting, part of Mantu, is seeking a Senior Clinical Research Associate to oversee multi-site clinical studies, with a focus on cardiac electrophysiology. The role requires strong leadership and regulatory know-how, plus the ability to travel up to 80% of the time.

You'll coordinate site activities, ensure data quality, and liaise between sites and the clinical team, while supporting patient recruitment and training initiatives.

Qualifications

• Bachelor’s degree with at least 4 years of relevant experience.
• Clinical research and medical device monitoring experience required.
• Understanding of regulations and standards in clinical research and medical devices/combination products.
• Relevant industry certifications (e.g., CCRA, RAC, CDE) preferred.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint).
• Ability to travel up to 80% of the time.
• Fluency in English and Dutch; French is preferred.

Responsabilités

• Manage clinical study activities for multiple sites across single or several clinical projects.
• Oversee performance of appointed study sites, including site visits, monitoring, communication, and deliverables.
• Serve as the liaison between the clinical study team and study site personnel.
• Ensure the safety and well-being of study subjects at assigned sites.
• Support operational execution of clinical trials and ensure collection of high-quality, substantiated data.
• Execute clinical trial activities in compliance with SOPs, GCP, and regulatory requirements.
• Accountable for study site performance and data quality according to project timelines.
• Assist in resolving issues and implementing corrective/preventive actions as needed.
• Verify Investigator Site Files are maintained according to regulations and company procedures.
• Support patient recruitment and retention activities.
• Ensure study site compliance with protocols and all applicable regulations.
• Assist with internal communication of clinical data and events.
• Support organization of investigator and study training meetings.
• Act as a reliable resource for up-to-date study site status.
• Support the implementation of new clinical systems/processes.
• Interface and collaborate with investigators, IRBs/ECs, vendors, and company personnel.
• Comply with all applicable laws, regulations, and company policies.

Connaissances

Leadership

Communication

Presentation skills

Influencing skills

Organizational skills

Travel availability

English and Dutch proficiency

Formation

Bachelor’s degree in a relevant field

Outils

Microsoft Office

Description du poste

Amaris Consulting, part of Mantu, is seeking a Senior Clinical Research Associate to oversee multi-site clinical studies, with a focus on cardiac electrophysiology. The role requires strong leadership and regulatory know-how, plus the ability to travel up to 80% of the time.

You'll coordinate site activities, ensure data quality, and liaise between sites and the clinical team, while supporting patient recruitment and training initiatives.