Do you want to work for an innovative specialist spinal implant company and play a pivotal role in advancing medical research?
If yes, come to join our clinical studies team as Clinical Project Manager.
(2-year fixed term contract)
Main Mission:
The Clinical Project Manager is 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.
Your daily responsibilities will include:
- Developing and managing clinical study plan and study budget.
- Coordinating the study protocol and key study document development, and studing reports as needed.
- Ensuring effective communication of study status to all stakeholders.
- Leading study project team meetings, ensuring gaps, risks, actions and decisions documented and communicated.
- Overseeing site selection
- Conducting or overseeing site initiation, monitoring and site closure and maintaining regular and effective communication with sites.
- Ensuring quality control of study documents and maintaining study quality metrics.
- Training and overseeing monitors (CRAs), the timeliness and quality of their work.
- Overseeing study 3rd party suppliers (CRO, image analysis, others).
Your profile:
- Qualifications within Biological Science, Pharmacy, Medicine, Nursing, or another relevant life sciences discipline.
- Minimum 3 years of recent experience in clinical study management within medical device industry class II & III medical devices; spine surgery would be an advantage.
- Very good communication, motivational, organisational
- Fluency in English with excellent study document writing skills; Advanced French written and oral. Both will be daily working langage