Clinical Research Associate

Role location: Aix-en-Provence, France

Here at Hologic the opportunities to grow, progress and unleash your talents are immense. Join us in a role that will affect the lives of millions. Unleash your true potential and drive your success in a company that is as ambitious and future focused as you are.

As Clinical Research Lead you will be responsible for organizing clinical evaluation need to verify ultrasound device development. You will have knowledge of standards and regulations of clinical evaluation, excellent communication and negotiation skills and natural curiosity about new technology. This is a great new role where you will have the opportunity to experience the full lifecycle of a project, join a fantastic team and award winning workplace environment.

KEY RESPONSIBILITIES

• Develop, write protocols to perform clinical trials
• Identify, evaluate, and select of clinical trial investigators/sites
• Estimate budget, resources, means to perform trials
• Estimate risks, setup mitigation and process to manage risks withing the trials frame
• Conduct trials from investigator/site identification to closeout, visit trials sites and ensure compliance with the approved protocol
• Verify and review collected information and provide support to R&D, regulatory, marketing teams by presenting reports on significant findings, deviations, deficiencies, and recommended actions

KNOWLEDGE, SKILLS & EXPERIENCE

• Degree in clinical research or in biomedical engineering
• Experience in a similar role
• Excellent communication and presentation skills
• Knowledge of ISO 13485, European Medical Device Regulation 2017/745, GCP, ICH GCP E6; ISO 14155:2020
• Knowledge of the US Quality Management System Regulation 21 CFR part 820 – is highly desirable
• Ability to travel worldwide and to work in an international environment; fluent written and spoken English and French