Senior Clinical Research Associate (CRA) – Medical Devices (F/M/X)

Job description

As a Senior CRA, you will play a key role in the successful execution of clinical investigations for medical devices. You will oversee site management activities, ensure regulatory compliance, and support clinical project teams across various client engagements. Your project experience will allow you to contribute beyond monitoring by supporting study planning, operational excellence, and stakeholder management.

Key Responsibilities

Perform site feasibility, qualification, initiation, routine monitoring, and close-out visits.

Ensure clinical investigations are conducted in accordance with ISO 14155, ICH-GCP, MDR (EU 2017/745), applicable local regulations, and study protocols.

Monitor site performance, patient safety, protocol compliance, and data quality.

Build and maintain strong relationships with investigators, clinical sites, sponsors, and cross-functional teams.

Identify operational risks and proactively drive issue resolution.

Support Clinical Project Managers with study planning, timelines, and project execution.

Review essential documents and ensure inspection readiness throughout the study lifecycle.

Contribute to process improvements and share best practices across projects.

Mentor junior CRAs where appropriate.

Your Profile

Master's degree or higher in Life Sciences, Biomedical Sciences, Biomedical Engineering, Pharmacy, Medicine, or another relevant scientific discipline.

At least 5 years of experience as a Clinical Research Associate, preferably within the Medical Device industry.

Demonstrated experience supporting clinical projects beyond routine monitoring activities.

Strong knowledge of ISO 14155, MDR (EU 2017/745), ICH-GCP, and applicable regulatory requirements.

Experience working in multidisciplinary and international project teams.

Excellent stakeholder management and communication skills.

Fluent in English and Dutch.

Willingness to travel throughout the Netherlands for site visits.

What We Offer

The opportunity to work with multiple leading Medical Device companies across the Netherlands.

Diverse and challenging clinical projects within an international consulting environment.

Continuous learning and career development through dedicated training and coaching.

A collaborative, entrepreneurial, and multicultural company culture.

Competitive salary and an attractive benefits package.

Clear career progression opportunities within Amaris Consulting.

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 reason, 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 is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 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