Zimmer Biomet Z

Clinical Project Lead 100% m/f (BB-33D58)

Gefunden in: Xpatjobs CH

Beschreibung:

Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.
We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.
For our manufacturing site in Winterthur (Switzerland) we are looking for a:

Clinical Project Lead 100% m/f

The Clinical Project Lead (CPL) is responsible for broad aspects of clinical study development, initiation, monitoring and management. In addition and as requested by other teams especially by Clinical Strategy or Post Market Surveillance, the CPL will support new product development by counseling the team on relevant clinical aspects that needs to be taken into consideration during the development phase as well as by writing Clinical Evaluation Reports needed to supporting regulatory submissions.

Your main responsibilities:
  • Responsible for broad aspect of clinical study development and support
    • Clinical studies include regulatory approval monitored studies, prospective randomized control trials and mono- and multicenter outcomes studies (Post-Market Surveillance)
    • The support includes site start-up, data quality maintenance, report generation and presentation development
  • Conduct site visits including site assessment, interim monitoring for appropriate patient enrollment and documentation compliance and close out or termination visits
    • Lead presentation of study design, clinical program and contractual agreements to potential investigators
    • Conduct training of research coordinators and surgeon office staff on data collection methods
  • Support submission of protocols to ethics committees and competent authorities for review and approval
  • Collaborate with biostatisticians to design study databases, evaluate data and assist in producing surgeon requested analysis and presentations on clinical results
  • Consult with marketing and engineering staff concerning risk analysis, clinical assessments, clinical projects status, and results of the clinical trials
  • Consult with independent radiologists, and other outside consultants as required for study progress
  • Build strong relationships with surgeons and research staff involved in clinical research
  • Support regulatory and development efforts during the conformity assessment process (FMEA, Risk Management and PMS plan and report), as applicable
  • Perform literature research for study development, protocol development, case report form design and development of patient information and consent forms, as applicable
Your Qualifications and Experience:
  • Minimum of a Bachelor of Science Degree or equivalent education in technical area (biomedical sciences or engineering, medical or biology) with a preference for an advanced degree (PhD, MD)
  • Knowledge of medical device business, products, medical education and product development preferred
  • Preferred previous experience in clinical research of medical devices activities with direct responsibility for protocol submissions, development and content
  • Fluent written and spoken English is a must; Proficient written and spoken German and French is preferred
  • Self-motivated team-player, happy to work as part of an extended team
Travel Requirements:

This dynamic job position requires a willingness to travel.

This is a unique opportunity to develop your international experience and be a part of a truly global team. Zimmer Biomet offers a wide range of challenging career advancement opportunities and a dynamic work environment. We look forward to receiving your comple

calendar_todayvor 6 Tagen

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location_on Winterthur , Zurich, Schweiz

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