Clinical Project Specialist H/F
Permanent Contract (CDI)
- Education: Master of Science in Engineering (biomedical, sciences) or equivalent
- Experience: 5 years minimum of related experience with clinical and pre-clinical project management
- Desired Experience: Experience in an international environment
Clinical Project Specialist H/F
As a Clinical Project Specialist, you will work in the Clinical Affairs Team under the management of the Chief Clinical Officer.
Inside this team, your missions will be to work hand in hand with the clinical project leader of the associated markets
You will have to travel occasionally in Europe as part of developing relationships with the physicians, visiting hospitals for clinical studies, etc.
- Contribute to evaluate the need for clinical evidence for development projects.
- Elaborate all necessary clinical affair related research and documents required for regulatory and R&D purposes (bibliography search, CEP, CER, etc).
- Elaborate the design of the studies in light of the expressed needs (R&D, regulatory, market, etc).
- Generate clinical (pre and post-market) and pre-clinical study protocols as well as supporting documentation required to obtain the corresponding Research Ethics Committees approvals.
- Ensure trials are conducted in full compliance to GLP, GCP and all other applicable regulatory requirements and quality procedures.
- Ensure all studies are documented clearly and concisely for regulatory submissions and publications.
- Coordinate the successful execution of trials and studies (animal and clinical) with Quantum’s other departments and with pre-clinical/clinical partners.
- Analyze data, write, and publish clinical reports.
- Ensure relationships with service providers and monitor results.
- Contribute to the scientific watch of existing clinical data or clinical studies to design.
- You have a Master of Science in Engineering (biomedical, sciences) or equivalent.
- You have at least 5 years minimum of related experience with clinical and pre-clinical project management.
- You have a strong knowledge of clinical best practices and standards for clinical trials and studies (ISO 14155)
- You have an experience of Quality Management System and Design Control
- You are able to work in multidisciplinary teams.
- You have strong analytical and problem-solving skills
- You have excellent communication and documentation skills
- You are pragmatic and customer-oriented approach
- You are highly proficient in oral and written English
- The knowledge of German or Italian is a plus.
Working at Quantum Surgical means:
- Joining a talented, dynamic, and multicultural team whilst being part of the technological and human adventure of a company in full evolution.
- Sharing our culture of innovation, team spirit and result-oriented
- Taking up technical challenges
- Benefiting from a competitive compensation (fixed salary+ variable, BSPCE)
Diversity is one of our strong beliefs. We therefore carefully study every application without any consideration that could be related to either physical or moral characteristics.
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