About Graftys
Founded in 2005 and based on the research works of Pr. Jean-Michel Bouler (CEISAM/CNRS), Graftys develops, manufactures and markets patented synthetic bone biomaterials, in particular new generations of resorbable calcium-phosphate cements, for reconstructive orthopedic surgery. Within the 3 million annual procedures bone graft market, the bone cement market segment is one of the fastest-growing. The Company's key products - Graftys® Quickset fast setting/high viscosity and Graftys® HBS lower viscosity/high injectability cements - are commercialized in more than 25 countries, including Europe and the United States of America, through distribution partnerships. The objective of the Company is to develop its existing activities especially in key markets such as Europe and the USA, to enter new high-potential markets such as Asia (China, Japan...) where the Company is not present yet and expand the Company product lines by offering new versions of existing products and new products with enhanced regenerative properties.
For more information: http://www.graftys.com

To strengthen our growing organization, Graftys is looking for a « Clinical Study Manager » (M/F).

You will be in charge of:
- Management and coordination of clinical trials: phase I/II and III
- Participate to study design and protocol development
- Medical writing of study related documents: protocols, IB, ICF, CRF, …
- Preparation of regulatory documents and submission files to EC and CA
- Site relationship: investigators, site selection, initiation visits, investigator agreement preparation, organization of investigator/meetings, monitoring activities
- Review of clinical trial data, support in preparation of clinical study reports
- Management of vendors
- Review of medical literature and related new technologies, and close collaboration with other departments (preclinical, regulatory, production, QC, IP…)

Your Profile
- A minimum of an advanced scientific degree (PhD, DVM, MD)
- Experience in clinical operations: minimum of 5 years
- Good knowledge of ISO, GCP - ICH principles
- Experience within biotech/medtech and R&D environment,
- Autonomous team player, strong interpersonal and communication skills
- Able to work within start up medtech environment
- Reactive to deadlines, pro-active, dynamic and problem solving
- Fluent in English and French;

Our Offer
- Immediate start
- Full-time
- Long-term contract (CDI)
- Attractive salary
- Position mainly based in Gosselies (Belgium)

This opportunity to integrate an innovative company motivates you? Do you want to join a dynamic and fast-growing company? Do not hesitate to send your resumé with a motivation letter to [email protected]

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