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Clinical Trial Coordinator

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QTC are partnered with a Dutch scale up specialising in the development of medical products for maternal and fetal health monitoring. They currently have 2 fully completed CE-certified products in the EU market and are in the process of expanding to the US with the FDA. Due to continued growth, we are searching for a Clinical Trial Coordinator to join the organisation and oversee 2 sets of clinical obstetric studies, one in the EU and the other in the US.

Details

Clinical Research

Clinical Research

Veldhoven - Netherlands

40 hours per week

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QTC logo icon About your role

This is how you will make the difference

Responsibilities: Design and manage clinical studies to validate company products and services. Develop study documents (Protocols, Data Management Plan, Statistical Analysis Plan, etc.) and coordinate with clinical trials partners for site communication. Work with clinical data to monitor quality and escalate technical issues. Oversee clinical research projects, ensuring timely delivery of milestones and coordination of study execution. Manage regulatory documentation for audit readiness. Visit clinical sites in Europe and the US for study setup, monitoring, and compliance with regulations and guidelines. Report progress to the clinical and algorithm teams, as well as executive management. Develop and maintain study materials in compliance with regulations. Provide guidance on best practices for clinical study design and execution.

QTC logo icon what's needed

What you bring

Profile:

 

Minimum BSc degree in Clinical or Biomedical focus

2+ years of experience running clinical trials for medical devices.

Experience designing and managing multi-site clinical studies.

Experience with ethics committees, IRB, and regulatory bodies.

Familiarity with Good Clinical Practice (ISO 14155).

Knowledge of digital health products and connected devices.

Experience with data visualisation and scientific software.

Experience with CE marking or FDA certification trials.

Experience running Randomised Controlled Trials (RCTs).

QTC logo icon What we offer

What's in it for you

Offer:

 

Competitive salary with strong secondary benefits

Scale-up environment with new office

Training and development budget

International work environment with global scope

Hybrid working 

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