Clinical Project Lead
Vor 7 Tagen
**Job Summary**: 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. **Principal Duties and 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 - Write Clinical Evaluation Reports needed for regulatory submissions, as applicable **_ This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions”_** **Expected Areas of Competence**: **Special expertise**: - Research / Technical publication and/or technical writing experience beneficial - Knowledge of medical device business, products, medical education and product development preferred **Personal skills requirements**: - Possess strong oral and written communication skills - Self motivated Team-player, happy to work as part of an extended Team **Education/Experience Requirements**: **Education**: Minimum of a Bachelor of Science Degree or equivalent education in technical area (biomedical sciences or engineering, medical or biology, etc.) with a preference for an advanced degree (PhD, MD) **Professional experience**: - Advanced Microsoft Office Suite and general computer software skills - Preferred previous experience in clinical research of medical devices with direct responsibility for protocol submissions, development and content **Languages**: - Fluent written and spoken English is a must - Preferred multilingual **Travel Requirements**: - Up to 40 %
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Clinical Project Lead
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Winterthur, Schweiz Zimmer Biomet VollzeitThe 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...
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Team Leader, Clinical Affairs
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Winterthur, Schweiz Sulzer Ltd VollzeitSulzer is a leading engineering company with a proud heritage of innovation. Join our global team to grow your expertise and develop innovative solutions that enable a prosperous and more sustainable society. We offer you a wealth of opportunities to drive your career into the direction that you want, depending on your skills and interests. We invite you to...
