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For your reference, we have included the original job posting below.




THV Clinical Product/Implant Specialist


Job Number:25058814
Company Name:Edwards Lifesciences
Job Location:Maurepas, FR
Job Category:Healthcare & Medical
 

THV Clinical Product/Implant Specialist
Title: THV Clinical Product/Implant Specialist
Req #: 4475
City: Maurepas

State: France

Country: France

Function: Clinical Affairs

Responsibilities: Role Purpose:
Responsible for providing clinical support and technical assistance to investigators and site personnel involved in the use and implantation of investigative and commercial Edwards transcatheter valve and delivery system products in the hospital setting.

Works in close cooperation and collaboration with
. Trial Managers/Clinical Research Specialists (CRAs) to achieve clinical trial/registry enrollment objectives.
. Research & Development Engineers to facilitate product development and iteration.
. Clinical Sales Specialists & Marketing personnel to prepare and assist customers for commercial use of THV products.
. Logistics and Country Customer Service to identify center product needs for clinical trials & maintain device accountability
. Direct investigator/customer interface

Major Job Functions:
. Coordinate and conduct training in assigned clinical sites of personnel (physicians and hospital team members) in the appropriate use of investigative Edwards aortic and pulmonary transcatheter valve and delivery system components.
. Be responsible for initial and subsequent investigative product ordering through local country EW Customer Service departments during the enrollment phase of the clinical trial.
. Provide Trial Manager with study site product forecasts where appropriate.
. Assist site study personnel in the review and documentation of products delivered to the institution (Packing Slips) including initiation and documentation of Return Goods Authorizations (RGA) and timely completion of Device Accountability documents.
. Assist in the delivery and collection of documents necessary for Edwards transcatheter study initiation and conduct (e.g. Ethics Committee, Ministry of Health, Hospital Administration, Site Study Personnel)
. Assist Principle Investigators/Study Site Personnel in the evaluation of patient screening/enrollment activities in Edwards THV clinical trials, evaluations and registries including the review and presentation of patient pre-screening assessments of available cardiovascular images.
. Be present and assist in product preparation where indicated in aortic or pulmonary transcatheter valve interventions in assigned clinical sites.
. Provide a written summary of the clinical implantation for assigned trials.
. Support marketing and sales activities for commercialized THV products including identification/evaluation of THV site criteria and being available to cover implantations when necessary.

Requirements: Required Education/Skills:
· University degree or equivalent in a natural science or medical field desired
· English (written & spoken), At least one additional European language desired
· Computer skills - Microsoft Office (Winword, Excel, Access, Powerpoint, Project), Internet, Calendar systems
· Good communication and organizational skills
· Thorough, conscientious and results oriented working style
· Independent judgment skills & action orientation for obtaining required results
· Team orientation and skills to facilitate team work

Required Experience:
· Experience/knowledge in sterile techniques used in the hospital environment.
· Experience/knowledge in cardiac catheterization laboratory or operating room techniques preferred.
· Experience/knowledge of interventional devices/materials and how to use them.
· Knowledge of Diagnostic Imaging (CT/Angiography/Fluoroscopy/Echography) and hemodynamic monitoring.
· Knowledge of European and international regulations for Good Clinical Practice and ISO standards related to Clinical Research in Human Subjects (ISO 14155)


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