Clinical Affairs PM: Brain Robotics & Trials

Robeauté; France; On-site; EUR 70,000 - 110,000; Full time

Job summary

Robeauté is seeking a Clinical Affairs Project Manager to lead the planning, organization and execution of GLP preclinical and early clinical studies for its robotic brain therapy platform.

You will collaborate with the Head of Clinical and surgeon collaborators across geographies, coordinate CROs, prepare regulatory submissions (IDE) and contribute to scientific communications and publications.

Qualifications

• At least 5 years of experience in preparation and execution of clinical trials with medical devices.
• Experience with GLP preclinical studies and regulatory submissions (IDE preferred).
• Device testing in lab and clinical environments.
• Strong written and spoken English; French preferred.

Responsibilities

• Design GLP preclinical and clinical studies with surgeon collaboration.
• Write preclinical and clinical protocols.
• Prepare ethics and regulatory documentation (IDE, local authorities).
• Manage clinical site contracts and CRO selections.
• Oversee GLP and clinical study management and reporting.
• Coordinate with surgeon KOLs on study design and execution.
• Collect, curate and analyze study data; ensure data quality.
• Support medical affairs, conferences and publication pipelines.

Skills

Clinical trial planning

Study execution

GLP preclinical experience

English writing skills

Education

MD, Master’s or Ph.D. in Life Sciences / Biomedical Engineering

Job description

Robeauté is seeking a Clinical Affairs Project Manager to lead the planning, organization and execution of GLP preclinical and early clinical studies for its robotic brain therapy platform.

You will collaborate with the Head of Clinical and surgeon collaborators across geographies, coordinate CROs, prepare regulatory submissions (IDE) and contribute to scientific communications and publications.