The Project Manager will be responsible for managing clinical studies on Spineart products from study set up to study closure, ensuring high quality and integrity of data, and compliance with relevant SOPs, regulatory requirements, timelines and within budget :
- Develops and manages clinical study plan and study budget.
- Coordinates the study protocol and key study document development, and study reports as needed.
- Ensures effective communication of study status to all stakeholders.
- Oversees site selection
- Conducts or oversees site initiation, monitoring and site closure and maintains regular and effective communication with sites.
- Trains and oversees monitors (CRAs) and the timeliness and quality of their work.
- Oversees study 3rd party suppliers (CRO, image analysis, others).
- Bachelor’s degree equivalent or higher qualification within Medicine, Biological Science, or another relevant life sciences discipline
- Minimum 3 years of recent experience in clinical study management within medical device industry (Spine would be an advantage). Experience with class II & III medical devices preferred.
- Preferred experience includes clinical trials, post market studies, study monitoring, safety reporting, submissions, report writing, literature reviews, study budget management.
- Knowledge and experience of Good Clinical Practice (GCP) and regulations relating to medical device studies.
- Project management skills required to include the use of a formal process and system for planning and tracking ongoing progress of clinical projects.
- Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines.
- Travel up to approximately 25%.
- Fluency in English and French. Spanish or German an advantage.