Job Description

This is a new role, you will be responsible for driving and overseeing the day-to-day operations of clinical trials and studies (investigator-initiated trials and company-sponsored trials).

Your responsibilities:

• Oversee the smooth running of clinical trials as per protocol, in accordance with regulatory and ethical standards.
• Support the process of the protocol definition with internal and external stakeholders
• Write, amend, and submit clinical trial documentation to partners and ethical committees and accompanying patient information material
• Collect, and organizing documents and data obtained from research according to best practices for data privacy and regulatory compliance (as per FDA / MDR guidelines)
• Select, establish and manage the relationship with contract research organizations (CROs)
• Train the study team on study protocol and on proper usage of company medical products
• Liaise between study team and clinical and product development teams to provide technical support and continuous feedback
• Contribute to the management of assigned budget

Qualifications

• Bachelor's degree in biomedical, nursing or a related field
• Training/experience in neuroscience/neuro-engineering/neurorehabilitation is a plus
• Proven experience (5+ years) in clinical project execution, preferably in (neuro)rehabilitation and medical device industry ; experience with Software as Medical devices (SaMD) and training in project management is a plus
• In-depth knowledge of ICH-GCP, the Medical Device Directive: understanding of US and European medical device clinical trial approval procedures
• Experience in developing and managing clinical trial budgets, as well as in working with external contract research organizations
• Superior analytical and organizational skills: attention to detail and accuracy
• Very good written, verbal, and interpersonal communication skills
• Fluent level of English

Additional Information

** Please note that the job title listed in this posting is not set in stone and may be adapted to better reflect the skills and experience of the ideal candidate.**

Benefits Overview

• Health Insurance
• Paid time off
• Dental insurance
• 401(k)
• Vision insurance
• Flexible schedule
• Life insurance
• 401(k) matching
• Employee discount
• Flexible spending account
• Health savings account

Mindmaze provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.