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Clinical Study Manager

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Medical Device - Gosselies

Founded in 2005, Graftys develops, manufactures and markets patented synthetic bone biomaterials for reconstructive orthopedic surgery. Graftys is specialized in new generations of resorbable calcium-phosphate cements and is based on the research works of Pr. Jean-Michel Bouler (CEISAM/CNRS).

 The Company’s key products are commercialized in more than 25 countries, including Europe and the USA, through distribution partnerships. The objective of Graftys is to expand the company product lines by offering new versions of existing products and new products with enhanced regenerative properties.

Graftys, one of the world leaders in resorbable bone cements, is based in Belgium and France. For more information about the company, please visit www.graftys.com.

In order to support the expansion of the dynamic team in Gosselies, we are looking for a (m/f):

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Clinical Study Manager

Responsibilities:

As a Clinical Study Manager, you lead and coordinate clinical trials (phases I, II and III) from study design and protocol development to the study close-out and clinical data review.

Your main responsibilities are as follows:

  • You manage and coordinate clinical trials of phases I, II and III and/or medical device equivalents.
  • You participate to study design and protocol development.
  • You deal with the medical writing of study related documents: protocols, IB, ICF, CRF…
  • You prepare regulatory documents and submission files to EC and CA.
  • You manage site relationships: investigators, site selection, initiation visits, investigator agreement preparation, organization of investigator/meetings, monitoring activities
  • You ensure the review of clinical trial data, support in preparation of clinical study reports
  • You manage vendors.
  • You review medical literature and related new technologies, and close collaboration with other departments: preclinical, regulatory, production, QC, IP…
Profile:
  • You hold an advanced scientific degree: PhD, DVM, MD.
  • You have at least 5 years’ experience in clinical operations, ideally in the implantable medical device or in the biotech industry.
  • You have good knowledge of ISO & GCP-ICH principles.
  • You show excellent oral and written communication skills and strong interpersonal skills.
  • You demonstrate a good sense of organization, responsibility and flexibility.
  • You are fluent in French and English, written and spoken. Knowledge of another language is an asset.
Offer:
  • A challenging and rewarding position within a fast-growing company.
  • The opportunity to join a company specialized in innovative product for reconstructive orthopedics.
  • To work in a human-sized, innovative, collaborative and dynamic company.
  • A full-time permanent contract (CDI) with an attractive salary package in line with your experience.
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Your application and related information will remain strictly confidential.

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