Senior Clinical Research Associate (F/M/X)

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

Senior Clinical Research Associate (F/M/X)

Permanent Job

As a Senior Clinical Research Associate, you will be responsible for managing clinical activities and ensuring the successful execution of clinical studies, particularly in the field of cardiac electrophysiology.

Your missions

• 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.

Your profile

• Bachelor’s degree with at least 4 years of relevant experience.
• Previous 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.
• Clinical/medical background is a plus.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint).
• Strong leadership, communication, presentation, and influencing skills.
• Excellent organizational skills; ability to manage multiple tasks and meet deadlines.
• Ability to travel up to 80% of the time.
• Proficiency in English and Dutch required; French is preferred.

What we offer

Joining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression.

In practical terms, here’s what this means for you on a daily basis:

Projects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM…) and the support of our internal Centers of Excellence. You get the depth, not just the breadth.

Real management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure — proof that we build something that lasts.

A career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression — not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility are actively encouraged.

Innovation, in practice 291 AI agents built in-house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact.

CSR with real targets SBTi carbon reduction roadmap, 32% women in management (target: 34.3% by 2029), social engagement through We Care Together.

Health insurance, remote work, meal vouchers, time savings account, referral bonus... We'll discuss the full benefits breakdown during our meetings.

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting, part of Mantu is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.