Senior Clinical Research Associate (F/M/X)

Amaris Consulting | Part of Mantu; Diegem; Sur place; EUR 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting is recruiting a Senior Clinical Research Associate to manage clinical activities in cardiac electrophysiology across multiple sites. You will oversee site performance, ensure data quality, and liaise between the study team and site personnel.

You will ensure patient safety, support trial execution, and comply with SOPs and regulatory requirements, including GCP. Fluency in English and Dutch is required, with some French preferred.

Qualifications

• Bachelor’s degree with at least 4 years of relevant experience.
• Experience in clinical research and medical device monitoring.
• Knowledge of GCP and regulatory requirements.
• Certifications such as CCRA, RAC, CDE preferred.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint).
• Strong leadership, communication, and organizational skills.
• Ability to travel up to 80%.
• Proficiency in English and Dutch; French preferred.

Responsabilités

• Manage clinical study activities across sites and projects.
• Monitor performance of study sites and coordinate visits.
• Liaise between study team and site personnel.
• Ensure patient safety and data quality per timelines.
• Ensure compliance with SOPs, GCP, and regulatory requirements.
• Support recruitment and retention activities.
• Maintain Investigator Site Files per regulations.
• Collaborate with investigators, IRBs/ECs, vendors, and staff.

Connaissances

Clinical research

Medical devices

Regulatory knowledge

Leadership

Communication

Organizational skills

Travel readiness

English and Dutch

Formation

Bachelor's degree

Outils

MS Office

Description du poste

Job Description

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.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here’s what our recruitment process looks like:

Brief Call

Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews

During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study

Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!