Medacta® is an international orthopaedics company specializing in the design and production of innovative orthopaedic products and the development of accompanying surgical techniques. Established in 1999 in Switzerland, Medacta’s products and surgical techniques are characterized by innovation. Medacta is a pioneer in developing new offerings on the basis of the minimally invasive surgical techniques, in particular its Anterior Minimally Invasive Surgery (AMIS®) technique for hip replacements. Medacta has leveraged its orthopaedic expertise and comprehensive understanding of the human body to develop the sophisticated MySolutions technology, which offers surgeons highly personalized pre-operative planning and implant placement methodologies by creating advanced personalized kinematic models and 3D planning tools for use in hip, knee, shoulder and spine procedures.
Medacta is looking for a Project Manager, Clinical Research to join the team in Franklin, TN! A successful person in the position would be someone who has the ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues. Able to read, analyze, and interpret complex technical documents and manuals and define problems, collect data, establish facts, and draw valid conclusions.
Medacta USA is located in Cool Springs/Franklin, TN. Medacta values medical education, innovation and healthcare sustainability!
The Principal Duties of the role are as follows:
Supports prospective and retrospective clinical research initiatives.
Manage clinical research and operations including design and initiation of clinical trials to optimize tactical and clinical value through U.S. site selection and data portability.
Coordinate and oversee clinical trials to support regulatory submissions (PMA, IDE, 510(k)), as well as post-market clinical trials and clinical preference evaluations.
Clinical study project management including:
Case Report Form (CRF) Development
Site Management and Study Monitoring
IRB Approvals and Management
Site Qualification Visits
Site Initiation Visits
Training the Clinical Sites to the study protocol
Site Close Out Visits
Work with external sites to ensure expedient patient recruitment in conjunction with CRO.
Participate in defining clinical application of Medacta products and contribute in the development of post-market clinical studies
Author and/or work with others to develop publications based on the results of the clinical trials.
Provide updates and status reports to senior management on a regular basis; report on performance against plan.
Support the development of the clinical research budget. Help ensure overall operation is within the approved budget and timeline.
Develop and implement SOPs for clinical research/trials and related activities
Ensure compliance with all applicable regulatory standards related to clinical research/trials and interactions with physicians
Develop and maintain professional relationships with academic and community-based physicians, clinicians and investigators to assure good clinical input to the product development process, marketing, and field sales force
Interface with departments within and outside of the company Accounting, R&D, Regulatory Affairs, Product Development and Marketing.
Manage outside partners/service providers
Represent the company at major annual conferences
Travel requirement up to 40%.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel sofied.