Are you a passionate individual with a strong background in clinical project management?
Are you dreaming of a job with a real impact on patients ’lives?
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!
Together we can shape the future of the healthcare.
As clinical project manager you will be responsible be 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 main responsibilities will be:
- Developing and managing the clinical study plan, study budget, risk identification and mitigation.
- Coordinating the key study document developments, including the protocol and reports.
- Ensuring clear and aligned communication with stakeholders, between project team members and with the clinical site investigators and teams.
- Overseeing all study processes including site selection and management, monitoring and data management, safety management and vendor management.
- Leading study project teams, ensuring clear roles and responsbilities, issues and other risks are addressed swiflty and escalated as needed.
- Ensuring quality control of study documents and maintains study quality metrics.
- Training and overseeing monitors (CRAs) and quality of their work.
- Conducting and maintaining an up to date literature review by study.
- Contributing to continuous improvement initiatives, including WI writing.
- Contributing to PMCF plan, PMCF report and other regulatory clinical documents
The Clinical Project Manager is expected to travel approximately 25% of the time.
Your profile:
- Minimum 3 years of recent experience in clinical study management within medical device industry, class II & III medical devices preferred, spine surgery would be an advantage.
- Project management skills such as use of a formal process and system for planning and tracking ongoing progress of clinical projects.
- CRO and other Vendor management experience.
- Bachelor’s degree equivalent or higher qualification within Biological Science, Pharmacy, Medicine, Nursing, or another relevant life sciences discipline.
- Very good communication skills including the ability to to adjust communication style, to motivate the project team and investigational sites, and the ability to present complex information to both clinical and non-clinical disciplines.
- An individual who takes ‘ownership’ and who is also a team player
- Fluency in English (working language of the team) and advanced French written and oral.
Who we are :
Our success also depends on our team’s value. The human being is at the centre of our concerns. We pay special attention to our recruitment to make Spineart a great place to work.
For us, soft skills are as important as hard skills. What we expect from our employees is nothing short of real team spirit, mutual assistance, and self-transcendence.
Our philosophy: Quality, Innovation, Simplicity
Our values: Respect, Integrity, Solution oriented