Les offres d'emploi : Professions sociales - Santé ...

As Clinical Trial Manager you will be responsible for coordinating global clinical trial activities according to internationally recognized ethical principles and GCP regulations and that data generated is suitable for successful worldwide regulatory submissions.
Key responsibilities include:
-Planning, implementing, and supervising of clinical trial studies collaborating with CROs, project leaders and physicians in accordance with project objectives, timelines and budgets.
-Insurance of a high level of GCP compliance on all clinical trial activities.
-Review and approve monitoring reports appropriating corrective measures as required.
-Plan and track trial country and centre activity, including IEC and regulatory submissions, contracts and other GCP documents.
-Prepare specific document data package to obtain IRB/IEC permission for the study.
-Clinical trial data documentation, data handling and evaluation for the production of the Final Clinical Study Report.
-Collaborative set up and maintenance of the Trial Master Files for the studies.
-Organisation of drug distribution, accountability and return of investigational drug supplies as well as assisting in SAE reporting.
-Ideally you have sound scientific and practical knowledge within the field of operations, management, as well as having a sharp attention to detail which enables the objectives to be achieved with the highest possible quality.
-You hold a BS or MS in Natural Science with preferably at least 3 years of clinical trial management experience within the biotech/pharmaceutical industry, including delegation of tasks, demonstrated supervisory and planning skills.
-A proven ability to identify and resolve complex clinical trial methodology problems is essential.
-The ability to lead a team with highly effective interpersonal skills and the ability to work independently.
-Excellent communication skills and fluency in written and spoken English an absolute necessity.
Kuros is a biomedical company based in Zurich focused on the development of novel injectable materials for localized therapy. They are bringing new products to the market to repair and regenerate injured or diseased tissue and is currently involved in developing proprietary products which provide both cellular support and therapeutic drugs to a tissue site with impaired healing.
The versatility of the technology makes it ideal for addressing a number of therapeutic areas, including spinal surgery, dermatology, drug delivery, infection and pain control.
Your application will be sent to Terence O'Hare (Zurich Office)
Please quote the reference VTOH16650