We are looking for a Clinical Affairs Manager to implement and oversee all activities related to clinical research and clinical studies in the company.
DiA Imaging Analysis provides AI-powered solutions to make ultrasound image analysis smarter and more accessible.
Its AI-based solutions help ultrasound users acquire the right image and analyze it automatically, allowing them to identify clinical abnormalities that are often difficult to find visually and enabling them to make better decisions based on accurate and objective data.
Your role:
Designing and managing the execution of clinical studies that demonstrate medical product safety and efficacy.
Ensuring that trials are conducted in full compliance to GCP.
Full responsibility on sites initiation, site personnel training and monitoring.
Working closely with the principal investigators and study coordinators.
Working with regulatory, development and marketing teams to create scientific publications, clinical marketing material and clinical background required for regulatory submissions.
Requirements: You're the right fit if you have:
Bachelors degree in biomedical engineering, Biology, or similar Certified as CRA.
Minimum of 3 years of experience as a clinical affairs manager.
Experience in managing and monitoring clinical studies: writing protocols, working with medical staff and managing the clinical budget.
Familiarity with regulatory requirements - clinical summaries and Clinical evaluation report for submission to the regulatory authorities.
Experience in writing scientific publications an advantage.
Experience working for a medical software company in the field of medical Imaging an advantage.
Familiarity with the field of ultrasound - an advantage.
This position is open to all candidates.